Ann Arbor , MI , United States
Conducts internal audit activities including review of study reports study protocols informed consents etc. The Auditor GCP Compliance will conduct internal and external audit activities for the GCP/GLP Compliance Activities, schedules and conducts external domestic and foreign field audit activities including CROs and non-clinical facilities. Participates in system audits of internal processes and procedures. • Provides GCP/GLP compliance representation to clinical teams. • Provides input into the development of department SOPs. • Presents GCP Compliance perspectives at investigator meetings and other internal functions. • Participates in the training of new employees
Requirements • Minimum of 5+ years related pharmaceutical industry experience preferably in Clinical Quality Assurance clinical research or field monitoring. • Excellent knowledge of FDA GCP GLP and ICH guidelines and regulations. • 1-2 years previous GLP auditing / laboratory experience and / or computer validation compliance is preferred. • Excellent medical/scientific written and verbal communication skills. • Good computer skills in MS Word Outlook Excel and PowerPoint. 25% travel is required.
• EDUCATION: B.S. in the Life Sciences.
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