******************************************************************************* title: QA Auditor company: Roche location: Nutley, NJ name: Frank Bosley phone: 973-230-8647 email: racerboy@att.net payment: credit Date: 02/19/2006 responsibilities: QA GLP Studies ******************************************************************************* title: QA Auditor company: Roche location: Nutley, NJ name: Frank Bosley phone: 973-230-8647 email: racerboy@att.net payment: credit Date: 02/19/2006 responsibilities: QA GLP Studies ******************************************************************************* title: Vice President, Global Quality Assurance company: Omnicare Clinical Research location: King of Prussia, PA name: Human Resources phone: email: Careers@OmnicareCR.com payment: credit Date: 02/21/2006 responsibilities: Omnicare Clinical Research is currently seeking a Vice President of Global Quality Assurance. Responsibilities include: „X Establish company policies through SOPs etc. regarding interpretation/implementation of Good Clinical Practice; advise Omnicare Clinical Research staff regarding GCP compliance and training. „X Establish policies for Global CQA operations; oversee Global CQA functions of consulting, auditing, validation, and SOP administration. „X Facilitate other departments¡¦ enhancement of their quality of services provided to sponsors. „X Oversee budgets of US and International CQA; oversee development of CQA sections of project proposals. „X Coordinate, host, and facilitate follow-up of audits of Omnicare Clinical Research by sponsors and FDA; provide guidance for inspections by other regulatory agencies. „X Oversee development and implementation of US and International Master Quality Plans for non-contracted CQA audits and other internal services. „X Represent Global CQA at meetings of the Corporate Executive Committee, other management teams, and other departments, and at external meetings. Join the Omnicare Clinical Research team! Join us for our industry leadership, our innovative solutions, and our aggressive growth. Omnicare Clinical Research is one of the world¡¦s leading clinical research organizations, providing full-service capabilities across all therapeutic areas and all phases of clinical drug development. You will have the satisfaction of knowing that your experience and intelligence is working to improve the quality of medicine and the quality of life for people around the globe. With 29 offices world-wide, Omnicare Clinical Research is headquartered in King of Prussia, Pennsylvania. To learn more about us, visit our website at www.OmnicareCR.com. For consideration, please forward a copy of your resume to Careers@OmnicareCR.com or write to Human Resources, Omnicare Clinical Research, 630 Allendale Road, King of Prussia, PA 19406. ******************************************************************************* title: Clinical Auditor - Senior Clinical Auditor company: Duramed Research, Inc location: Bala Cynwyd, PA name: Jay Bradley phone: 201-930-3422 email: jbradley@barrlabs.com payment: credit Date: 02/23/2006 responsibilities: Duramed Research, Inc., a subsidiary of Barr Pharmaceuticals, Inc. located in Bala Cynwyd, PA is a specialty proprietary pharmaceutical company that develops, manufactures and markets unique proprietary pharmaceuticals. We are currently seeking auditors and senior auditors to support our growing clinical quality assurance operations. Position: Clinical Auditor/Senior Clinical Auditor Description: · Ensure that Duramed Research processes, procedures and activities are in compliance with Federal Regulations and cGCPs. · Conducting and/or overseeing audits of clinical sites and clinical study reports. · Conducting and/or overseeing audits of outside vendors such as CROs, contract labs, and/or IRBs. · Conducting internal audits of Duramed processes and SOPs · Providing CQA representation to project teams · Assisting in the creation and maintenance of CQA SOPs and audit tools · Investigating and resolving compliance problems and questions regarding Regulatory Affairs, Clinical Operations, Data Management, BioStatistics, and Safety · Conducting GCP Training · Assist with hosting regulatory agency inspections · Other Duties as assigned Requirements: · MS/BS degree in Scientific Discipline/ Life Sciences · 1-5 years experience in Clinical Quality Assurance · Thorough knowledge of Good Clinical Practices (GCPs), quality systems (SOPs) and audit procedures and reporting · Applying principals of 21 CFR Part 11 to clinical systems · Capable of writing effective SOPs, Quality Assurance Reports and training materials · Ability to communicate effectively and non-confrontationally with internal departments · Ability to multi-task and work in a fast paced environment · Capable of planning activities to meet CQA objectives · Ability to resolve / document quality problems as appropriate and know when to elevate problems to a higher level · Responsible for conducting GCP compliance activities for Duramed Research, Inc. · Ability to travel 20% of the time Duramed Research, Inc offers competitive salaries and a comprehensive benefits package including a stock purchase plan and a 401(k) plan with a generous company match. Please forward resume to rdcareers@barrlabs.com ******************************************************************************* title: Quality Assurance Auditor-GCP Project Compliance company: ICON Clinical Research location: North Wales, PA name: Kelly Spak phone: 215-616-3373 email: spakk@iconus.com payment: credit Date: 03/10/2006 responsibilities: TEAMWORK The Ultimate Symbiotic Relationship Focusing on a common goal. Performing your job accurately so that the next person can do theirs. That's how we work together at ICON Clinical Research. Because at ICON, your personal best is the valuable link in the teamwork we need to achieve quality results. Working with ICON, you'll share in a unique culture of a large company that emphasizes a warm, friendly environment. This is where career possibilities can become realities... where those who look for challenges, embrace the learning and growth opportunities we offer. ICON Clinical Research is dedicated to providing the pharmaceutical and biotechnology industries with exceptional clinical research and biometrics services, and we're the first international CRO awarded ISO 9001:2000 quality certification across all divisions and functions. QUALITY ASSURANCE AUDITOR - GCP PROJECT COMPLIANCE North Wales, PA and Redwood City, CA The successful candidate will be responsible for evaluating GCP and other relevant regulatory requirements within ICON as well as investigator site compliance. The position will also require conducting quality assurance audits of clinical trial data and records including audits of clinical databases, investigator sites, monitoring files and study files. Position will involve approximately 25-35% travel on average. The qualified candidate will have a Bachelor's degree in the Life Sciences, Nursing, or an equivalent mix of college and experience equivalent to a 4 year degree. Must have familiarity with GCP guidelines and relevant clinical trial regulations. At least 1 ½ years of in-field monitoring experience as a Clinical Research Associate/Site monitor preferred. GCP auditing experience desirable. Must possess excellent communication and organization skills along with strong MS Office skills. Come to ICON and be an important part of a well respected and growing company that believes the details of your career are every bit as critical as the work you do. You'll enjoy highly competitive benefits in addition to flexible scheduling, relocation assistance, tuition reimbursement, credit union, health club privileges, and many other exceptional advantages. TO APPLY and for more information on our opportunities and locations, please visit us at http://www.iconclinical.com/index.asp?getpage=true&sid=10 . No agencies, please. ICON. We are the right solution. ICON Clinical Research is an Equal Opportunity Employer committed to strength in diversity. www.iconclinical.com ******************************************************************************* title: Quality Engineer company: Fresco System USA location: Telford, PA name: Faith Frisbie phone: 215-721-2960 email: ffrisbie@fresco.com payment: credit Date: 03/22/2006 responsibilities: QUALITY ENGINEER Fres-co System USA, Inc., a leader for over 25 years in flexible packaging, sells and services packaging equipment and materials to Fortune 500 customers in both dry and liquid market segments including coffee, institutional and retail food, chemicals, pet food and other industrial applications. Fres-co is headquartered in Telford, Bucks County, PA. Fres-co holds Gold Standard AIB Certification. More information is available at www.fresco.com. Position Responsibilities: To develop and implement inspection and test methods, drive SPC implementation, analyze data, conduct internal and external audits. Requirements: Engineering degree or equivalent; Experience: 3—5 years in AIB or ISO 9000 environment; Software: advanced MS Office; Ability to work in fast paced, customer focused environment handling multiple projects; Experience in roto or flexo printing, extrusion, or laminating in a flexible packaging environment a plus. ******************************************************************************* title: Senior Clinical QA Auditor company: ImClone Systems Incorporated location: Branchburg, New Jersey name: Susan Fairman phone: 908.541.8027 email: sfairman@imclone.com payment: credit Date: 03/31/2006 responsibilities: Participates in the strategic planning and implementation of the clinical QA (CQA) plan. Conducts GCP audits of ImClone sponsored clinical trials, CROs, clinical laboratories and internal ImClone processes. Issues audit reports, recommends corrective action and conducts follow up to audits and corrective actions. Keeps ImClone Management informed of compliance status. Assists in preparation of GCP compliance summaries/trends. Assists in the management of CQA consultants/CROs. Prepares investigational sites for FDA inspection. Assists with preparation for sponsor inspection and may act as health authority escort for sponsor and/or clinical site. Reviews and recommends compliance related policies/procedures; provides training when necessary. Evaluates impending regulations, guidelines and industry standards and their impact on the clinical trials and the company. Note this position requires approximately 40% travel. 1.Contributes to the strategic CQA planning and conducts GCP audits of ImClone sponsored clinical trials, CROs, clinical laboratories and internal ImClone processes. 2.Provides assurance that clinical trials are conducted and that data generated and reported are in compliance with protocols, GCP, regulatory requirements through document reviews and audits. 3.Conducts audits to evaluate internal processes related to conduct and reporting of clinical trials to assure compliance with study protocols, SOPs, GCP, and regulatory requirements. 4.Issues audit reports, recommends corrective action and may conduct follow up to audits and corrective actions. 5.Provides timely written reports to inform management of ImClone’s regulatory status based on audits of CROs, investigator sites and internal audits of ImClone's processes. 6.Prepares investigational sites for FDA inspections. Acts as on-site escort for health authority inspections as needed. 7. Responsible for clinical trial complaints process according to SOP. 8.Performs GCP / CQA training as needed. May present GCP QA at investigator’s meetings. 9.Develops Clinical QA Standard Operating procedures, CQA compliance tracking tools, and audit worksheets as required. 10. Assists with the management of CQA consultants / CROs. 11.Attends GCP/GMP training programs as required. 1.A BA/BS degree in the sciences, R.N. or equivalent experience. 2.Minimum of 5 years experience in the Biopharmaceutical industry including at least 3 years experience auditing clinical sites and CROs, clinical laboratories, clinical study reports, or internal systems. Previous monitoring experience is preferred but not required. 3.Demonstrates a thorough knowledge of GCP federal regulations and ICH guidelines and other regulations as applicable. 4.Excellent written and oral communication skills and must be computer literate. 5.Must be a self-starter and have the ability to work in a start-up environment. ******************************************************************************* title: Quality Assurance Specialist - Neptune, NJ company: MDS Pharma Services location: Neptune, NJ name: Jake Lee phone: 800.554.0502 ext. 623 email: jake.lee@mdsinc.com payment: credit Date: 04/10/2006 responsibilities: Considering a career in clinical research? We have an exciting opportunity as a Quality Assurance Specialist at our Neptune, NJ location. The QA Specialist will assure management that records, methods, and practices are consistent with corporate policy and regulatory requirements. Essential Job Functions: *Review reports, source documents and raw data to assure management that they accurately reflect study protocols, MDS Pharma Services SOPs/policies and regulations *Conduct systems audits and issue reports to management to assure compliance with MDS Pharma Services SOPs/policies and regulations *Assist with inspections by sponsors and regulatory authorities re:quality processes at MDS Pharma Services Administrative responsibilities (SOPs, training, etc) Qualifications: *Bachelor's degree in Business, Science, or related field *Clinical data management or training experience preferred *QA experience preferred *Excellent oral and written communication skills *Ability to organize and manage multiple priorities To apply, please visit our online hiring center at www.mdsps.com. ******************************************************************************* title: Quality Assurance Auditor-Part Time company: Tandem Labs location: West Trenton NJ name: Jane Nelson phone: 609-434-0044 email: jane@tandemlabs.com payment: credit Date: 04/17/2006 responsibilities: QUALITY ASSURANCE AUDITOR-Part Time Job responsibilities for this position include performing audits and inspections of facilities, projects, and reports. The qualified candidate must possess a minimum of an Associates degree in a life science field or equivalent experience. The candidate should have a functional knowledge of MS Office and Access. Auditing experience in a GLP environment with bioanalytical or toxicology setting is preferred. The ideal candidate will have 1-2 years GLP auditing experience and must be an effective team player with excellent interpersonal, communication and written skills. Must have effective time management skills and the ability to prioritize and organize tasks. Must be able to work in a deadline-oriented environment. ******************************************************************************* title: QA Auditor company: Tandem Labs location: W Trenton, NJ name: Jane Nelson phone: 609-434-0044 email: jane@tandemlabs.com payment: credit Date: 05/12/2006 responsibilities: Tandem Labs, a contract bioanalytical laboratory providing specialized services for the pharmaceutical industry, is looking for qualified individuals for its Quality Assurance Unit in West Trenton, NJ. QUALITY ASSURANCE AUDITOR Job responsibilities for this entry-level position include performing audits and inspections of facilities, projects, and reports. The qualified candidate should possess a minimum of an Associates degree in Biology, Chemistry or applicable life science field. The candidate should have a functional knowledge of MS Office and Access. Experience in a GLP bioanalytical or toxicology environment with bioanalytical auditing is a plus. The ideal candidate must be an effective team player with excellent interpersonal, communication and written skills. Must have effective time management skills and the ability to prioritize and organize tasks. Must be able to work in a deadline-oriented environment. Tandem Labs offers a competitive salary and excellent benefits package, including 401K, and health, dental insurance plans. Please send your resume to: Tandem Labs 115 Silvia Street West Trenton, NJ email jane@tandemlabs.com Fax (609) 434 0033 Equal Opportunity Employer M/F/V/D ******************************************************************************* title: GLP QA Auditor (Req S&MA2698) company: Sanofi-aventis location: Bridgewater, NJ name: Posting Department phone: 708-358-0463 email: shakerpostings3@shaker.com payment: credit Date: 05/17/2006 responsibilities: Career matters. Life matters. Health matters. At the heart of all that matters are people, connected in purpose by career, life, and health. Throughout the world and here at home, sanofi-aventis fight for what is essential to us all – health. Now one of the world's largest pharmaceutical company, our R&D organization has created a superior product portfolio and one of the industry's richest pipelines that will set the course for improving the health of millions worldwide. Your expertise in your field and your passion for science and discovery will ensure we continue to improve the health of millions... because health matters. Job Responsibilities: Ensure compliance with applicable GLP regulations, SOPs, study plans, and sanofi-aventis policies by auditing non-clinical safety and pharmacokinetic studies, facilities, Contract Research Organizations, vendors/suppliers and provide timely and accurate reporting of audit findings. Assure corrective action activities are completed and provide training to operational personnel. Provide regulatory guidance to internal and external customers in order to improve the quality of their activities consistent with applicable regulatory guidance, current SOPs, and policies. Actively participate in inspections by Regulatory Authorities. • Maintains knowledge of sanofi-aventis policies, procedures and directives as well as US and international regulations and guidelines associated with preclinical pharmaceutical regulatory issues. • Schedules and performs audits of all the various phases of non-clinical studies. Determines compliance with applicable GLP regulations, SOPs and associated guidelines. Accurately summarizes and reports findings. Assists in developing, implementing, and monitoring corrective actions. Prepares a QA Statement that is included with the study report. • Conducts in-depth internal and external audits in support of non-clinical studies. Assist in the determination of whether external providers are able to conduct studies and/or provide services for sanofi-aventis to the required quality levels. Report audit findings to operational and Q&C management and follow-up on responses. Assures critical issues are raised to site GLP manager. • Develops and conducts GLP regulatory training sessions for non-clinical personnel, operational personnel supporting GLP activities, and GLP staff. Provides guidance to study, facility and laboratory management and staff relating to preclinical regulatory issues concerning study conduct, documentation, reporting and facilities. • Assists the Q&C GLP Manager overseeing FDA regulatory site visits/inspections and interacts with regulatory authorities during the inspection. • Participates in team projects as a Q&C GLP representative for the validation of computerized systems and/or equipment. • Specific global or local responsibilities which include review of SOPs for departments operating under, or supporting, GLPs. Prepares SOPs concerning the specific Q&C GLP activities. Interacts with senior personnel on significant matters that often require coordination between organizations. Job Qualifications: • B.S/B.A degree in a scientific or related discipline or equivalent technical experience • Minimum of 6 years experience in a GLP environment with 3 years experience in a GLP Quality Assurance Unit • Scheduled and performed GLP audits of non-clinical drug safety and farm activities and support services both on-site and of external subcontractors and suppliers • Actively participated in inspections performed on-site by Regulatory Authorities • Knowledge of FDA and International Regulations and Guidelines on GLPs and industry practices pertaining to the design and performance of non-clinical safety and farm studies in the pharmaceutical industry • Knowledge of computers with the ability to audit online computerized data • Ability to actively participate in the validation of computerized systems and the qualification of equipment • Effective written and oral communication skills and the ability to tailor communications to a particular audience • Skilled in developing and maintaining good interpersonal relationships • Ability to partner with others and to work independently Response Information: Driven by a pioneering spirit, a strong set of core values and a mosaic of talent worldwide, we strive for success - in health. In doing so, we strengthen careers and enrich lives. Discover your future with sanofi-aventis. Apply online. www.careers.sanofi-aventis.us (Apply to Req S&MA2698) Sanofi-aventis is an equal opportunity employer that embraces diversity to foster positive, innovative thinking that will benefit people worldwide. Sanofi-aventis is also committed to employing qualified individuals with disabilities and, where warranted, will provide reasonable accommodation to applicants, as well as its employees. ******************************************************************************* title: Clinical Q&C Senior Specialist, GCP (Req S&MA2228) company: Sanofi-aventis location: Malvern, PA name: Posting Department phone: 708-358-0463 email: shakerpostings3@shaker.com payment: credit Date: 05/17/2006 responsibilities: Career matters. Life matters. Health matters. At the heart of all that matters are people, connected in purpose by career, life, and health. Throughout the world and here at home, sanofi-aventis fight for what is essential to us all – health. Now one of the world's largest pharmaceutical company, our R&D organization has created a superior product portfolio and one of the industry's richest pipelines that will set the course for improving the health of millions worldwide. Your expertise in your field and your passion for science and discovery will ensure we continue to improve the health of millions... because health matters. Job Responsibilities: The SMA Clinical Q&C Senior Specialist is responsible for the initiation, conduct, and follow-up of audits as assigned by C Q&C Management, including all interaction with involved operational staff (e.g. Project Teams, Clinical Operations, Pharmacovigilance, etc.) within the frame of the mission and responsibilities defined hereafter. This also includes responsibilities as Clinical Project Representative for projects as assigned by C Q&C management. The position reports to the Director GCP and / or Associate Director GCP. Duties & Responsibilities: 1)Independently prepare, conduct, report, and follow-up on audits according to the SMA Clinical Q&C SOPs, the agreed audit strategy, audit program, and objectives. Audits include project / study related audits, and may also include audits of processes / systems associated with clinical research and pharmacovigilance processes and audits of CROs. 2)Act as a Clinical project Representative (CPR) for assigned clinical projects. 3)May participate in the training on C Q&C activities and other topics related to GCP, Regulations, and Guidelines, etc. 4)Participate in the preparation, implementation and periodic revision of C Q&C SOPs and working methodologies 5)May participate, in liaison with C Q&C Management, in selected Clinical Regulatory Inspections including preparation, escorting inspectors, and communicating information about inspection processes and results. 6)Participate in knowledge updates in areas pertaining to C Q&C and to Regulations / Guidelines / Good Practices through review of literature and participation in relevant internal and external meetings/workshops/symposia. Job Qualifications: Bachelor's degree in a life / medical / natural sciences or scientific discipline or equivalent, 6 to 9 years of experience with BA; 4 to 7 years with advanced degree, e.g. MBA, MS, PharmD, PhD. This includes a minimum of 4 years of Clinical Quality Assurance related experience and/or experience in Clinical Trials such as Monitoring or Clinical Trial Management with good performance. Good working knowledge of international regulations/Guidelines/Good Practices pertaining to the clinical domain (Clinical Development, Pharmacovigilance and Regulatory Affairs. Good working knowledge of standard computer office software such as Word, Email system (Outlook, Lotus, etc.), PowerPoint and Excel. Current regulatory knowledge essential. Response Information: Driven by a pioneering spirit, a strong set of core values and a mosaic of talent worldwide, we strive for success - in health. In doing so, we strengthen careers and enrich lives. Discover your future with sanofi-aventis. Apply online. www.careers.sanofi-aventis.us (Apply to Req S&MA2228) Sanofi-aventis is an equal opportunity employer that embraces diversity to foster positive, innovative thinking that will benefit people worldwide. Sanofi-aventis is also committed to employing qualified individuals with disabilities and, where warranted, will provide reasonable accommodation to applicants, as well as its employees. ******************************************************************************* title: Quality Assurance Auditor company: SFBC Taylor location: 301D College Road East, Princeton, NJ name: Tony Jones phone: 609 951 0005 ext. 240 email: ajones@sfbci.com payment: credit Date: 05/22/2006 responsibilities: SFBC Taylor, a premier contract laboratory providing mass spectrometric bioanalytical services to the Pharmaceutical Industry, has a position currently available for a Quality Assurance Auditor, due to growth of our business. This is an excellent opportunity to work within a high-performance QA Team using state-of-the-art technology, and to gain GLP/QA experience working with a range of pharmaceutical industry clients in a non-animal environment. Preferred candidates will have a scientific background and at least 2 years of auditing experience (preferably GLP). Consideration will also be given to candidates with laboratory experience who wish to move into a QA role. The position will involve auditing all aspects of the company’s operations including analytical studies, facilities and computer systems (including application development and testing). SFBC Taylor offers a competitive benefits program with health, dental, vision and disability insurance, as well as 401K and share-purchase programs. We are committed to training and employee development. Qualified candidates should send resume and salary requirements to: SFBC Taylor 301D College Road East Princeton, NJ 08540 FAX: 609-951-0080 Email: seekjob@sfbctaylor.com ******************************************************************************* title: QA Auditor/Principal Specialist (Req S&MA3845) company: sanofi-aventis location: Bridgewater, NJ name: Lora Alejandro phone: 708-358-0428 email: lora.alejandro@shaker.com payment: credit Date: 06/08/2006 responsibilities: Company Profile: Career matters. Life matters. Health matters. At the heart of all that matters are people, connected in purpose by career, life, and health. Throughout the world and here at home, sanofi-aventis fight for what is essential to us all - health. Now one of the world's largest pharmaceutical company, our R&D organization has created a superior product portfolio and one of the industry's richest pipelines that will set the course for improving the health of millions worldwide. Your expertise in your field and your passion for science and discovery will ensure we continue to improve the health of millions... because health matters. Job Responsibilities: Ensure compliance with applicable GLP regulations, SOPs, study plans, and sanofi-aventis policies by auditing non-clinical safety and pharmacokinetic studies, facilities, Contract Research Organizations and vendors/suppliers, and provide timely and accurate reporting of audit findings. Provide regulatory guidance to internal and external customers in order to improve the quality of all activities associated with preclinical regulated studies consistent with applicable regulatory guidance. Assure corrective action activities are completed and provide training to Operational and GLP staff. Ensure solutions are consistent with organization objectives. Actively participate in inspections by Regulatory Authorities. Successfully design and oversee projects of simple to moderate scope and complexity. Contribute effectively to sound decision-making, act as a positive role model, and demonstrate sanofi-aventis values. 1. Schedules and performs audits of all the various phases of non-clinical studies. Determines compliance with applicable GLP regulations, SOPs and associated guidelines. Accurately summarizes and reports findings. Assists in developing, implementing, and monitoring corrective actions. Prepares QA statements. 2. Conduct in-depth internal and external audits in support of non-clinical studies. Participate in the determination of whether external providers are able to conduct studies and/or provide services for sanofi-aventis to the required quality levels. Report inspection findings to operational and Q&C management and follow-up on responses. Assure critical issues are raised to the site GLP manager. 3. Assist the Q&C GLP Manager during regulatory inspections and interact with regulatory authorities during inspections. Assist with the follow-up of all internal regulatory inspection reports and action plans to assure timely completion of corrective actions. 4. Participate in team projects as a Q&C GLP representative to deliver functional expertise and support. Perform activities with initiative and, with the guidance of the GLP Manager, work in a self-directed manner. Substitute for the GLP site manager as needed. 5. Provide guidance to study facility and laboratory management and staff relating to preclinical regulatory issues concerning study conduct, documentation, reporting and facilities. Provide training to GLP or operational staff as required. Positively influence the ideas, and align the efforts, of others by recognizing potential areas of process improvements; develop action plans and gain support for implementation. 6. Specific Global or local responsibilities which may include review of SOPs prepared by operational staff; preparation of SOPs concerning GLP activities, etc. Interact with senior personnel on issues that require coordination between organizations. Job Qualifications: Ability to actively participate in the validation of computerized systems and instrument qualification is a plus. A BS/BA degree in a scientific or related discipline or equivalent technical experience required. Must possess a minimum of 8 years experience in a GLP environment with 3-5 years of experience in a GLP Quality Assurance Unit. In-depth knowledge of FDA GLP requirements and industry practices pertaining to the design and performance of non-clinical safety and pharmacokinetic studies in the pharmaceutical industry is essential. A basic knowledge and understanding of EU requirements required. Must have working knowledge of auditing practices. Active participation in regulatory inspections or regulatory submissions essential. Must be able to schedule/perform moderate GLP audits of non-clinical drug safety & pharmacokinetic activities, and support services both on-site and at external contractors and suppliers. Team participation to implement process improvements in Q&C is important. Knowledge of computers and the ability to audit online computerized data is a must. Must be able to Travel up to 15%. Response Information: Driven by a pioneering spirit, a strong set of core values and a mosaic of talent worldwide, we strive for success - in health. In doing so, we strengthen careers and enrich lives. Discover your future with sanofi-aventis. Apply online. www.careers.sanofi-aventis.us Apply to Req S&MA3845 Sanofi-aventis is an equal opportunity employer that embraces diversity to foster positive, innovative thinking that will benefit people worldwide. Sanofi-aventis is also committed to employing qualified individuals with disabilities and, where warranted, will provide reasonable accommodation to applicants, as well as its employees. ******************************************************************************* title: Director, Compliance GQAC-GMP company: Schering-Plough location: Berkeley Heights, NJ name: Recruiter phone: 000-000-0000 email: noemails@no.com payment: credit Date: 06/19/2006 responsibilities: Our plans for tomorrow are as bold as yours. Schering-Plough has new drugs on the horizon, new partnerships and a renewed dedication to leadership, values and hard work — the same qualities that made us an industry leader for decades. Each day, we grow our relationships and establish the trust of doctors and patients alike, while providing them with a steady flow of the most innovative and effective science-based medicines and services. As we strive to achieve these goals, our commitment to building a diverse, global, highly skilled workforce has become even stronger, with performance driven incentives, leading edge training and development, and excellent opportunities for professional advancement. “We are building a new and special kind of healthcare company. The change, the excitement, the opportunity are infectious.” We currently have the following opportunity for our Berkeley Heights, NJ territory. Job Description: Direct audit function responsible for corporate audits and management notification as to the states of compliance of all Schering-Plough owned Global Supply Chain manufacturing, testing and distribution facilities worldwide, as well as all Schering-Plough owned clinical manufacturing and distribution facilities worldwide. Keep the Schering-Plough board of directors and senior management duly informed of our on-going compliance status as soon as possible to continue to meet the obligations of the GQAC-GMP charter. Education Bachelor of Science Skills: - 10+ Years of Biotechnology or Pharmaceutical Industry Experience - Superior Project Management Skills. - Outstanding GMP Compliance Auditing Skills - Extensive working knowledge of cGMP regulations is required as well as DEA , FDA and ICH regulations/guidance documents. - Demonstrated analytical and problem-solving skills, effective oral and written communication, with strong organizational and people management skills - Ability to Travel Domestic and International 25-35% - Ability to speak 2-3 languages. - Excellent Leadership Capabilities - BS in Life Science, Engineering or Related degree. As part of the Schering-Plough team, you’ll benefit from strong leadership, a new vision and an empowering corporate culture…while enjoying competitive compensation and a progressive benefits package. Schering-Plough is an Equal Opportunity Employer. To apply, please visit the Schering-Plough career website at http://www.schering-plough.com/schering_plough/careers/careers.jsp Click on the Search Jobs link, search openings and enter the Requisition ID (14461BR). ******************************************************************************* title: Associate Manager / Manager, Audits company: Schering-Plough location: Berkeley Heights name: Recruiter phone: 000-000-0000 email: noemails@no.com payment: credit Date: 06/22/2006 responsibilities: Our plans for tomorrow are as bold as yours. Schering-Plough has new drugs on the horizon, new partnerships and a renewed dedication to leadership, values and hard work — the same qualities that made us an industry leader for decades. Each day, we grow our relationships and establish the trust of doctors and patients alike, while providing them with a steady flow of the most innovative and effective science-based medicines and services. As we strive to achieve these goals, our commitment to building a diverse, global, highly skilled workforce has become even stronger, with performance driven incentives, leading edge training and development, and excellent opportunities for professional advancement. “We are building a new and special kind of healthcare company. The change, the excitement, the opportunity are infectious.” We currently have the following opportunity for our Berkeley Heights, NJ territory. Job Description Will join Global Quality Audits and Compliance GCP team performing GCP Systems and Process audits of the various business units GCP operations and sites located domestically and internationally. Audits are performed to evaluate compliance with all applicable local laws and SOPs and results are reported to appropriate auditees and SP Senior Management. Education Bachelor of Science Skills Bachelor's Degree in Life Science with four to nine years of relevant experience, including Quality Assurance auditing experience in a regulatory compliance environment. Solid understanding of applicable regulations. Strong verbal and written communications skills. Technical skills in GCP compliance disciplines. Ability to travel 25-30% worldwide/ Excellent organizational and interpersonal skills. As part of the Schering-Plough team, you’ll benefit from strong leadership, a new vision and an empowering corporate culture…while enjoying competitive compensation and a progressive benefits package. Schering-Plough is an Equal Opportunity Employer. To apply, please visit the Schering-Plough career website at http://www.schering-plough.com/schering_plough/careers/careers.jsp Click on the Search Jobs link, search openings and enter the Requisition ID (14877BR). ******************************************************************************* title: Associate Manager / Manager, Audits company: Schering-Plough location: NJ Berkeley Heights name: Recruiter phone: 000-000-0000 email: noemails@no.com payment: check Date: 06/22/2006 responsibilities: ur plans for tomorrow are as bold as yours. Schering-Plough has new drugs on the horizon, new partnerships and a renewed dedication to leadership, values and hard work — the same qualities that made us an industry leader for decades. Each day, we grow our relationships and establish the trust of doctors and patients alike, while providing them with a steady flow of the most innovative and effective science-based medicines and services. As we strive to achieve these goals, our commitment to building a diverse, global, highly skilled workforce has become even stronger, with performance driven incentives, leading edge training and development, and excellent opportunities for professional advancement. “We are building a new and special kind of healthcare company. The change, the excitement, the opportunity are infectious.” We currently have the following opportunity for our Berkeley Heights, NJ territory. Job Description: Will join Global Quality Audits and Compliance GCP team performing GCP Systems and Process audits of the various business units GCP operations and sites located domestically and internationally. Audits are performed to evaluate compliance with all applicable local laws and SOPs and results are reported to appropriate auditees and SP Senior Management. Education: Bachelor of Science Skills: Bachelor's Degree in Life Science with four to nine years of relevant experience, including Quality Assurance auditing experience in a regulatory compliance environment. Solid understanding of applicable regulations. Strong verbal and written communications skills. Technical skills in GCP compliance disciplines. Ability to travel 25-30% worldwide/ Excellent organizational and interpersonal skills. As part of the Schering-Plough team, you’ll benefit from strong leadership, a new vision and an empowering corporate culture…while enjoying competitive compensation and a progressive benefits package. Schering-Plough is an Equal Opportunity Employer. To apply, please visit the Schering-Plough career website at http://www.schering-plough.com/schering_plough/careers/careers.jsp Click on the Search Jobs link, search openings and enter the Requisition ID (15303BR). ******************************************************************************* title: Associate Manager / Manager, Audits company: Schering-Plough location: NJ Berkeley Heights name: Recruiter phone: 000-000-0000 email: noemails@no.com payment: check Date: 06/22/2006 responsibilities: ur plans for tomorrow are as bold as yours. Schering-Plough has new drugs on the horizon, new partnerships and a renewed dedication to leadership, values and hard work — the same qualities that made us an industry leader for decades. Each day, we grow our relationships and establish the trust of doctors and patients alike, while providing them with a steady flow of the most innovative and effective science-based medicines and services. As we strive to achieve these goals, our commitment to building a diverse, global, highly skilled workforce has become even stronger, with performance driven incentives, leading edge training and development, and excellent opportunities for professional advancement. “We are building a new and special kind of healthcare company. The change, the excitement, the opportunity are infectious.” We currently have the following opportunity for our Berkeley Heights, NJ territory. Job Description: Will join Global Quality Audits and Compliance GCP team performing GCP Systems and Process audits of the various business units GCP operations and sites located domestically and internationally. Audits are performed to evaluate compliance with all applicable local laws and SOPs and results are reported to appropriate auditees and SP Senior Management. Education: Bachelor of Science Skills: Bachelor's Degree in Life Science with four to nine years of relevant experience, including Quality Assurance auditing experience in a regulatory compliance environment. Solid understanding of applicable regulations. Strong verbal and written communications skills. Technical skills in GCP compliance disciplines. Ability to travel 25-30% worldwide/ Excellent organizational and interpersonal skills. As part of the Schering-Plough team, you’ll benefit from strong leadership, a new vision and an empowering corporate culture…while enjoying competitive compensation and a progressive benefits package. Schering-Plough is an Equal Opportunity Employer. To apply, please visit the Schering-Plough career website at http://www.schering-plough.com/schering_plough/careers/careers.jsp Click on the Search Jobs link, search openings and enter the Requisition ID (15303BR). ******************************************************************************* title: Associate Manager / Manager, Audits company: Schering-Plough location: NJ Berkeley Heights name: Recruiter phone: 000-000-0000 email: noemails@no.com payment: check Date: 06/22/2006 responsibilities: Our plans for tomorrow are as bold as yours. Schering-Plough has new drugs on the horizon, new partnerships and a renewed dedication to leadership, values and hard work — the same qualities that made us an industry leader for decades. Each day, we grow our relationships and establish the trust of doctors and patients alike, while providing them with a steady flow of the most innovative and effective science-based medicines and services. As we strive to achieve these goals, our commitment to building a diverse, global, highly skilled workforce has become even stronger, with performance driven incentives, leading edge training and development, and excellent opportunities for professional advancement. “We are building a new and special kind of healthcare company. The change, the excitement, the opportunity are infectious.” We currently have the following opportunity for our Berkeley Heights, NJ territory. Job Description: Will join Global Quality Audits and Compliance GCP team performing GCP Systems and Process audits of the various business units GCP operations and sites located domestically and internationally. Audits are performed to evaluate compliance with all applicable local laws and SOPs and results are reported to appropriate auditees and SP Senior Management. Education: Bachelor of Science Skills: Bachelor's Degree in Life Science with four to nine years of relevant experience, including Quality Assurance auditing experience in a regulatory compliance environment. Solid understanding of applicable regulations. Strong verbal and written communications skills. Technical skills in GCP compliance disciplines. Ability to travel 25-30% worldwide/ Excellent organizational and interpersonal skills. As part of the Schering-Plough team, you’ll benefit from strong leadership, a new vision and an empowering corporate culture…while enjoying competitive compensation and a progressive benefits package. Schering-Plough is an Equal Opportunity Employer. To apply, please visit the Schering-Plough career website at http://www.schering-plough.com/schering_plough/careers/careers.jsp Click on the Search Jobs link, search openings and enter the Requisition ID (14877BR). ******************************************************************************* title: skdjflk company: loijusdlimj location: ijolij name: lkjlk phone: lkjlk email: lkjlkj.com payment: credit Date: 06/23/2006 responsibilities: lkjlkj ******************************************************************************* title: QA Auditor/Principal Specialist (Req S&MA3845) company: sanofi-aventis location: Bridgewater, NJ name: Human Resources phone: 000-000-0000 email: do_not_use@mail.com payment: credit Date: 06/26/2006 responsibilities: Company Profile: Career matters. Life matters. Health matters. At the heart of all that matters are people, connected in purpose by career, life, and health. Throughout the world and here at home, sanofi-aventis fight for what is essential to us all - health. Now one of the world's largest pharmaceutical company, our R&D organization has created a superior product portfolio and one of the industry's richest pipelines that will set the course for improving the health of millions worldwide. Your expertise in your field and your passion for science and discovery will ensure we continue to improve the health of millions... because health matters. Job Responsibilities: Ensure compliance with applicable GLP regulations, SOPs, study plans, and sanofi-aventis policies by auditing non-clinical safety and pharmacokinetic studies, facilities, Contract Research Organizations and vendors/suppliers, and provide timely and accurate reporting of audit findings. Provide regulatory guidance to internal and external customers in order to improve the quality of all activities associated with preclinical regulated studies consistent with applicable regulatory guidance. Assure corrective action activities are completed and provide training to Operational and GLP staff. Ensure solutions are consistent with organization objectives. Actively participate in inspections by Regulatory Authorities. Successfully design and oversee projects of simple to moderate scope and complexity. Contribute effectively to sound decision-making, act as a positive role model, and demonstrate sanofi-aventis values. 1. Schedules and performs audits of all the various phases of non-clinical studies. Determines compliance with applicable GLP regulations, SOPs and associated guidelines. Accurately summarizes and reports findings. Assists in developing, implementing, and monitoring corrective actions. Prepares QA statements. 2. Conduct in-depth internal and external audits in support of non-clinical studies. Participate in the determination of whether external providers are able to conduct studies and/or provide services for sanofi-aventis to the required quality levels. Report inspection findings to operational and Q&C management and follow-up on responses. Assure critical issues are raised to the site GLP manager. 3. Assist the Q&C GLP Manager during regulatory inspections and interact with regulatory authorities during inspections. Assist with the follow-up of all internal regulatory inspection reports and action plans to assure timely completion of corrective actions. 4. Participate in team projects as a Q&C GLP representative to deliver functional expertise and support. Perform activities with initiative and, with the guidance of the GLP Manager, work in a self-directed manner. Substitute for the GLP site manager as needed. 5. Provide guidance to study facility and laboratory management and staff relating to preclinical regulatory issues concerning study conduct, documentation, reporting and facilities. Provide training to GLP or operational staff as required. Positively influence the ideas, and align the efforts, of others by recognizing potential areas of process improvements; develop action plans and gain support for implementation. 6. Specific Global or local responsibilities which may include review of SOPs prepared by operational staff; preparation of SOPs concerning GLP activities, etc. Interact with senior personnel on issues that require coordination between organizations. Job Qualifications: Ability to actively participate in the validation of computerized systems and instrument qualification is a plus. A BS/BA degree in a scientific or related discipline or equivalent technical experience required. Must possess a minimum of 8 years experience in a GLP environment with 3-5 years of experience in a GLP Quality Assurance Unit. In-depth knowledge of FDA GLP requirements and industry practices pertaining to the design and performance of non-clinical safety and pharmacokinetic studies in the pharmaceutical industry is essential. A basic knowledge and understanding of EU requirements required. Must have working knowledge of auditing practices. Active participation in regulatory inspections or regulatory submissions essential. Must be able to schedule/perform moderate GLP audits of non-clinical drug safety & pharmacokinetic activities, and support services both on-site and at external contractors and suppliers. Team participation to implement process improvements in Q&C is important. Knowledge of computers and the ability to audit online computerized data is a must. Must be able to Travel up to 15%. Response Information: Driven by a pioneering spirit, a strong set of core values and a mosaic of talent worldwide, we strive for success - in health. In doing so, we strengthen careers and enrich lives. Discover your future with sanofi-aventis. Apply online. www.careers.sanofi-aventis.us Apply to Req S&MA3845 Sanofi-aventis is an equal opportunity employer that embraces diversity to foster positive, innovative thinking that will benefit people worldwide. Sanofi-aventis is also committed to employing qualified individuals with disabilities and, where warranted, will provide reasonable accommodation to applicants, as well as its employees. ******************************************************************************* title: QA Auditor/Principal Specialist (Req S&MA3845) company: sanofi-aventis location: Bridgewater, NJ name: Human Resources phone: 000-000-0000 email: do_not_use@mail.com payment: credit Date: 06/26/2006 responsibilities: Company Profile: Career matters. Life matters. Health matters. At the heart of all that matters are people, connected in purpose by career, life, and health. Throughout the world and here at home, sanofi-aventis fight for what is essential to us all - health. Now one of the world's largest pharmaceutical company, our R&D organization has created a superior product portfolio and one of the industry's richest pipelines that will set the course for improving the health of millions worldwide. Your expertise in your field and your passion for science and discovery will ensure we continue to improve the health of millions... because health matters. Job Responsibilities: Ensure compliance with applicable GLP regulations, SOPs, study plans, and sanofi-aventis policies by auditing non-clinical safety and pharmacokinetic studies, facilities, Contract Research Organizations and vendors/suppliers, and provide timely and accurate reporting of audit findings. Provide regulatory guidance to internal and external customers in order to improve the quality of all activities associated with preclinical regulated studies consistent with applicable regulatory guidance. Assure corrective action activities are completed and provide training to Operational and GLP staff. Ensure solutions are consistent with organization objectives. Actively participate in inspections by Regulatory Authorities. Successfully design and oversee projects of simple to moderate scope and complexity. Contribute effectively to sound decision-making, act as a positive role model, and demonstrate sanofi-aventis values. 1. Schedules and performs audits of all the various phases of non-clinical studies. Determines compliance with applicable GLP regulations, SOPs and associated guidelines. Accurately summarizes and reports findings. Assists in developing, implementing, and monitoring corrective actions. Prepares QA statements. 2. Conduct in-depth internal and external audits in support of non-clinical studies. Participate in the determination of whether external providers are able to conduct studies and/or provide services for sanofi-aventis to the required quality levels. Report inspection findings to operational and Q&C management and follow-up on responses. Assure critical issues are raised to the site GLP manager. 3. Assist the Q&C GLP Manager during regulatory inspections and interact with regulatory authorities during inspections. Assist with the follow-up of all internal regulatory inspection reports and action plans to assure timely completion of corrective actions. 4. Participate in team projects as a Q&C GLP representative to deliver functional expertise and support. Perform activities with initiative and, with the guidance of the GLP Manager, work in a self-directed manner. Substitute for the GLP site manager as needed. 5. Provide guidance to study facility and laboratory management and staff relating to preclinical regulatory issues concerning study conduct, documentation, reporting and facilities. Provide training to GLP or operational staff as required. Positively influence the ideas, and align the efforts, of others by recognizing potential areas of process improvements; develop action plans and gain support for implementation. 6. Specific Global or local responsibilities which may include review of SOPs prepared by operational staff; preparation of SOPs concerning GLP activities, etc. Interact with senior personnel on issues that require coordination between organizations. Job Qualifications: Ability to actively participate in the validation of computerized systems and instrument qualification is a plus. A BS/BA degree in a scientific or related discipline or equivalent technical experience required. Must possess a minimum of 8 years experience in a GLP environment with 3-5 years of experience in a GLP Quality Assurance Unit. In-depth knowledge of FDA GLP requirements and industry practices pertaining to the design and performance of non-clinical safety and pharmacokinetic studies in the pharmaceutical industry is essential. A basic knowledge and understanding of EU requirements required. Must have working knowledge of auditing practices. Active participation in regulatory inspections or regulatory submissions essential. Must be able to schedule/perform moderate GLP audits of non-clinical drug safety & pharmacokinetic activities, and support services both on-site and at external contractors and suppliers. Team participation to implement process improvements in Q&C is important. Knowledge of computers and the ability to audit online computerized data is a must. Must be able to Travel up to 15%. Response Information: Driven by a pioneering spirit, a strong set of core values and a mosaic of talent worldwide, we strive for success - in health. In doing so, we strengthen careers and enrich lives. Discover your future with sanofi-aventis. Apply online. www.careers.sanofi-aventis.us Apply to Req S&MA3845 Sanofi-aventis is an equal opportunity employer that embraces diversity to foster positive, innovative thinking that will benefit people worldwide. Sanofi-aventis is also committed to employing qualified individuals with disabilities and, where warranted, will provide reasonable accommodation to applicants, as well as its employees. ******************************************************************************* title: Director, Compliance GQAC-GMP company: Schering-Plough location: Berkeley Heights, NJ name: Recruiter phone: 000-000-0000 email: noemails@no.com payment: check Date: 06/27/2006 responsibilities: Our plans for tomorrow are as bold as yours. Schering-Plough has new drugs on the horizon, new partnerships and a renewed dedication to leadership, values and hard work — the same qualities that made us an industry leader for decades. Each day, we grow our relationships and establish the trust of doctors and patients alike, while providing them with a steady flow of the most innovative and effective science-based medicines and services. As we strive to achieve these goals, our commitment to building a diverse, global, highly skilled workforce has become even stronger, with performance driven incentives, leading edge training and development, and excellent opportunities for professional advancement. “We are building a new and special kind of healthcare company. The change, the excitement, the opportunity are infectious.” We currently have the following opportunity for our Berkeley Heights, NJ territory. Job Description Direct audit function responsible for corporate audits and management notification as to the states of compliance of all Schering-Plough owned Global Supply Chain manufacturing, testing and distribution facilities worldwide, as well as all Schering-Plough owned clinical manufacturing and distribution facilities worldwide. Keep the Schering-Plough board of directors and senior management duly informed of our on-going compliance status as soon as possible to continue to meet the obligations of the GQAC-GMP charter. Education Bachelor of Science Skills - 10+ Years of Biotechnology or Pharmaceutical Industry Experience - Superior Project Management Skills. - Outstanding GMP Compliance Auditing Skills - Extensive working knowledge of cGMP regulations is required as well as DEA , FDA and ICH regulations/guidance documents. - Demonstrated analytical and problem-solving skills, effective oral and written communication, with strong organizational and people management skills - Ability to Travel Domestic and International 25-35% - Ability to speak 2-3 languages. - Excellent Leadership Capabilities - BS in Life Science, Engineering or Related degree. As part of the Schering-Plough team, you’ll benefit from strong leadership, a new vision and an empowering corporate culture…while enjoying competitive compensation and a progressive benefits package. Schering-Plough is an Equal Opportunity Employer. To apply, please visit the Schering-Plough career website at http://www.schering-plough.com/schering_plough/careers/careers.jsp Click on the Search Jobs link, search openings and enter the Requisition ID (14461BR). ******************************************************************************* title: Director of Quality company: Main Line Health location: Paoli, Pa name: Human Resources phone: N/A email: fitzpatrickk@mlhs.org payment: credit Date: 07/10/2006 responsibilities: EXCELLENCE at Face Value. Every day, we do our best to offer superior care and service. And every day we work to get even better. At Main Line Health you will find best-in-their-field people everywhere in our system. So if you strive for excellence, you will feel right at home with us. Paoli Hospital, one of Main Line Health’s acute hospitals, is currently seeking a full time Director of Quality to lead the quality improvement program for our hospital. This position will assure appropriate systematic monitoring and evaluation of the delivery of patient care for all departments. This position is also responsible for overseeing patient safety, infection control, patient satisfaction and improvement in those clinical measures. This position will also lead the reporting requirements to external agencies. An ideal candidate will have a bachelor’s degree in a healthcare field. A Masters in a healthcare related field preferred. A minimum of 5 years healthcare experience preferable within an acute care hospital. 3 years of quality improvement experience in an acute care setting. 5 years of management experience preferred. Paoli Hospital has earned Magnet Status and has been named one of Philadelphia Business Journal’s “Best Places to Work” in 2005. Main Line Health, as a whole, was presented the “2005 WorkforcePhiladelphia2.0 Award for Exemplary Learning Practices.” If you are interested in joining our Award Winning Hospital, please e-mail a resume to: fitzpatrickk@mlhs.org or fax to 610-645-8492. EOE ******************************************************************************* title: QA Specialist company: Advanced Biologics LLC location: New Hope PA name: Melissa Frank phone: 267-744-6194 email: m_frank@advbiol.com payment: credit Date: 07/14/2006 responsibilities: Preferred candidate will have a scientific back round and at least 2 years auditing experience in a GCP environment. Consideration will also be given to candidates with monitoring or regulatory experience who wish to move into the QA role. Summary of duties include auditing informed consents, trial master files, statistical reports, annual reports, protocols, clinical study databases, computer validation and clinical study reports. Conducting on-site audits of study investigators for compliance with GCPs, FDA regulations ICH guidelines, standard operating procedures and protocol adherence. Must be able to provide organized reports, work well in a team environment, be detail oriented, and have the ability multitask. Candidate must possess excellent communication and organization skills along with strong MS office skills. Position requires approximately 35% travel. http://www.advbiol.com/ ******************************************************************************* title: Auditor - Quality Assurance company: Schering-Plough location: Lafayette, NJ name: Recruiter Recruiter phone: 000-000-0000 email: noemails@no.com payment: check Date: 07/17/2006 responsibilities: Our plans for tomorrow are as bold as yours. Schering-Plough has new drugs on the horizon, new partnerships and a renewed dedication to leadership, values and hard work — the same qualities that made us an industry leader for decades. Each day, we grow our relationships and establish the trust of doctors and patients alike, while providing them with a steady flow of the most innovative and effective science-based medicines and services. As we strive to achieve these goals, our commitment to building a diverse, global, highly skilled workforce has become even stronger, with performance driven incentives, leading edge training and development, and excellent opportunities for professional advancement. “We are building a new and special kind of healthcare company. The change, the excitement, the opportunity are infectious.” Description: As a member of the Good laboratory Practices (GLP) Quality Assurance Unit perform domestic and international Good Laboratory Practices (GLP) audits that assess the company's compliance to FDA government regulations, scientific protocols and internal SOPs as they relate to the pre-clinical research process. Perform systems audits and due diligence reviews. Interpret and communicate findings. Develop and execute QA plans to meet regulatory compliance goals. Act as liaison with the FDA during inspections. Qualifications: BS degree in the Life Sciences. 2-4 year’s work experience in a regulated industry.Toxicology background required. Thorough knowledge of FDA Good Laboratory Practices Guidelines and Regulations. Technical skills in GLP compliance discipline and computer skills. The ability to develop and deliver effective oral and written presentations. Approximately 20-30% worldwide travel required. As part of the Schering-Plough team, you’ll benefit from strong leadership; a new vision and an empowering corporate culture…while enjoying competitive compensation and a progressive benefits package. We value the diversity of our global workforce. We are an equal opportunity employer. Schering-Plough is an Equal Opportunity Employer. To apply, please visit the Schering-Plough career website at http://www.schering-plough.com/schering_plough/careers/careers.jsp Click on the Search Jobs link, search openings and enter the Requisition ID (14772BR). ******************************************************************************* title: Document Control Specialist company: UPS Supply Chain Solutions location: Newark, DE name: Sue Young phone: 302-631-5117 email: smyoung2@ups-scs.com payment: credit Date: 07/24/2006 responsibilities: We are currently seeking a Document Control Specialist who impacts the organization by providing quality assurance support to the UPS SCS Healthcare organization by assisting in the centralized Document Control process. This position impacts the organization by communicating the quality policy and objectives and ensuring objectives are implemented and maintained. In this position the incumbent will participate in controlled document processing, tracking, distribution, retirement and archiving. Controlled documents including but are not limited to: SOPs, work instructions, forms, manual, validation documentation, AIPs, and QIRs (Quality Investigations). They will provide quality assurance/document control expertise and serve as a resource for UPS personnel and its’ clients. This position participates in the document control role in any client audits and agency inspections. A Bachelors degree in science, or healthcare is preferred. Equivalent work experience relevant to the job is considered. ASQ, RQAP-GLP, and/or RAPS certification a plus. Proficiency in English required. Proficiency in multiple languages (especially Spanish language) is a plus. Generally, 2 to 4 years experience in a FDA/DEA regulated business (e.g., pharmaceutical, medical device, healthcare, and/or biologics) is required. ******************************************************************************* title: Document Control Supervisor company: UPS Supply Chain Solutions location: Newark, DE name: Sue Young phone: 302-631-5117 email: smyoung2@ups-scs.com payment: Date: 07/24/2006 responsibilities: We are currently seeking a Document Control Supervisor who impacts the organization by providing quality assurance support to the UPS SCS Healthcare organization by managing the centralized Document Control process. This position impacts the organization by communicating the quality policy and objectives and ensuring objectives are implemented and maintained. In this position the incumbent will manage controlled document processing, tracking, distribution, retirement and archiving. Controlled documents including but are not limited to: SOPs, work instructions, forms, manual, validation documentation, AIPs, and QIRs (Quality Investigations). This person will supervise the document control staff to include, but not limited to Specialist(s), hourly(s) and temporary employees. This position will trend data to look for ways to improve quality processes. The QA Document Control Supervisor will coordinate and participate in the internal SOP review audit team(s), communicate effectively with the employees at all levels within UPS-SCS and/or clients, thoroughly understand regulatory issues as they relate to UPS-SCS and/or clients. This person will be involved in the implementation of and subsequent management of the electronic QMS (document management) system. They will provide quality assurance expertise and serve as a resource for UPS SCS personnel and its’ clients. A Bachelors degree in science, or healthcare is preferred. Equivalent work experience relevant to the job is considered. ASQ (CQM, CQE CQA), RQAP-GLP, and/or RAPS certification a plus. Relevant, on-going continuing education. Proficiency in English required. Proficiency in multiple languages (especially Spanish language) is a plus. Generally, five to seven years experience in a FDA/DEA regulated business (e.g., pharmaceutical, medical device, healthcare, and/or biologics). Work experience should have included responsibility for leading a team (prior supervisory experience is a plus), coordinating and executing audits, conducting research, and writing and revising SOPs. Knowledge of and working with document control systems/procedures is a must. Experience in interactions with regulatory agencies and/or experience in developing/delivering training programs is a plus. ******************************************************************************* title: QA Auditor I company: Charels River Laboratories location: Horsham, PA name: Cindi Willis phone: 215-957-2290 email: crjobs@us.crl.com payment: check Date: 08/17/2006 responsibilities: Charles River Laboratories is a global provider of solutions that advance the drug discovery and development process. Our leading-edge products and services are designed to enable our clients to bring drugs to market faster and more efficiently. To be a QA auditor you will help us in the preclinical sphere performing audits of protocols, raw data and final reports and performing inspections of laboratory operations and facilities REQUIREMENTS QUALIFICATIONS: • Education: Bachelor’s degree (B.S. /B.A.) or equivalent, preferably in a life science or related discipline. • Experience: Minimum of 1 to 2 years in a Quality Assurance role. • An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above. • Other: Experience with Microsoft Office® applications and spreadsheet programs such as Access and Excel. Position requires the individual to be able to communicate clearly, effectively and professionally; attention to detail and strong writing skills are essential.