Senior Auditor, Quality Assurance & Compliance

19428 Job posted on: 3/25/2008 At Covance, you can make a difference by helping to deliver life-saving and life-enhancing medicines to people around the world. Our commitment to this mission has resulted in Covance’s impressive history of company stability and growth. We’ve achieved these results by fostering a work environment that encourages, develops and leverages our team’s capabilities. Covance’s ongoing success offers team members unsurpassed growth and career development opportunities. There is no better time to join us! 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 SOP’s; supporting development of processes and SOP’s by process owners outside QA; represents QA on project teams and other internal forums and representing QA at client meetings and/or audits. Experience: Missing Education: A university/college degree (life science preferred) is required. · 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 · Strong analytical skills · Knowledge, understanding and experience in applying ICH/FDA Good Clinical Practices · Excellent oral, written and presentation skills · Excellent planning and organizational skills · Proven interpersonal skills · Demonstrated ability to handle multiple competing priorities across clinical operating units · 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 guidelines and GCP including international regulatory requirements for the conduct of clinical development programs. Knowledge of the drug development process from the perspective of a contract research organization is preferred. Covance is an Equal Opportunity Employer and is committed to diversity in the workplace At Covance, we help make the miracles of medicine a reality. We offer opportunities to work on diverse, challenging projects with bright, interesting colleagues while building a flexible and rewarding career. Covance is committed to diversity in the workplace and is an equal opportunity employer. (M/F/D/V). Your confidentiality and privacy are important to us. Save to job file |