Feb 01, 2017

Auditor GCP Compliance

  • Franklin Paterson
  • Ann Arbor, MI , United States
Full time Biotech Research Biotechnology

Job Description

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  

Job 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.


General-Other: R&D-Science



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