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