GCP Auditor Job

Company Name:
Salary period: Annual
A GCP Auditor is needed for a contract opportunity with Yoh's client located in Bridgewater, NJ.
Top Skills You Should Possess:
- Clinical Quality Assurance
- CRO Audits
What You'll Be Doing:
- The GCP Auditor Principal Specialist is responsible for the initiation, conduct, and follow-up of audits as assigned by CQA Management. Within the frame of the Principal Specialist's mission and responsibilities, the audits and activities require proven ability to independently interact with all internal and external (eg Vendors/CRO) operational staff (eg Project Teams, Clinical Operations, Pharmacovigilance, etc.) involved in the audited Clinical Research activities
- The GCP Auditor Principal Specialist's responsibilities also include the mission of GCP Project Representative for the projects assigned by CQA Management.
- The position reports to the Team Manager of CQA. The GCP Auditor Principal Specialist may be assigned as temporary backup for the CQA Team Manager.
- Independently prepare, conduct, report, and follow-up on audits according to the departmental SOPs, the agreed audit strategy, audit program, and objectives. Audits include project/study related audits, audits of processes/systems associated with clinical research and audits of CROs
- Lead routine and directed audits
- Act as a GCP Project Representative (GCP PR) for assigned clinical projects
What You Need to Bring to the Table:
- Bachelor degree preferably in a life/medical/natural sciences or scientific discipline
- 10 to 14 years of pharmaceutical (or related) experience with BA or 8 to 12 years with advanced degree, eg MBA, MS, PharmD, PhD. This includes a minimum of 6 years of Clinical Quality Assurance related experience and/or experience in Clinical Trials such as Monitoring or Clinical Trial Management with good performance
- Extensive 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
Get Hired, Apply Now!
Recruiter: Tonya Allen
Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer, M/F/D/V.

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