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Senior
Auditor, Quality Assurance and Compliance Covance, Inc.
Conshohocken, PA (Philadelphia, PA)
Covance is a world leader in
providing development services to manufacturers of medical products. Our
Periapproval office in Conshohocken, PA is seeking a Senior Auditor,
Quality Assurance and Compliance.
The Senior Auditor, Quality Assurance and Compliance will assure all
systems, processes and their outcomes comply with standards that meet
applicable international and national regulations and guidelines, and
fulfill client and Covance requirements; assure that all projects have
an Audit Plan written and assure that audits as defined in the project
Audit Plan are completed on time and within budget.
Responsibilities include, but are not limited to participating in
audits, as assigned, according to applicable SOP(s) and the project
Quality Plan; identifying non-conformances with requirements and
providing suitable recommendations; assuring that audit reports are
completed in a timely manner and that audit results are communicated to
auditees and management; ensuring suitable responses and action plans
provided by auditees; serving as a back up auditor to other QA&C staff;
participating in QA projects and supporting special projects requiring
QA input; contributing to process improvement initiatives across
organization; developing and maintaining global quality system to
recognized standards; participating in development of QA process and
SOPs; supporting development of processes and SOPs by process owners
outside QA; represents QA on project teams and other internal forums and
representing QA at client meetings and/or audits.
Education/Qualifications A university/college degree (life science
preferred) is required.
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Minimum of three (3) years experience in the pharmaceutical/CRO
industries, with at least two (2) years in Clinical Quality
Assurance, preferably within a GCP environment |
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Strong analytical skills |
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Knowledge, understanding and experience in applying ICH/FDA Good
Clinical Practices |
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Excellent oral, written and presentation skills |
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Excellent planning and organizational skills |
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Proven interpersonal skills |
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Demonstrated ability to handle multiple competing priorities across
clinical operating units |
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Ability to function as a member of a global clinical team |
The
Senior Auditor, Quality Assurance and Compliance has a proven ability to
understand, analyze and communicate the impact of global regulatory
issues affecting the drug development process; financial understanding
of global clinical development budgets and thorough knowledge of ICH.
Interested candidates should submit their
résumés to
robert.ossakow@covance.com |