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R&D QA Manager

R&D QA Manager, Pennsylvania, USA
PharmEng Technology is currently looking for a R&D QA Manager for a client site in PA. 
Job Description:
  • Write and approve SOPs, directives, policies pertaining to the testing of clinical trial materials, equipment operations, and quality procedures.
  • Review manufacturing records and analytical records.
  • Coordinate investigations and close deviations.  Follow up on CAPAs as needed.
  • Responsible for clinical batch release.
  • Candidate will represent R&D QA during all meetings.
 Job Requirements:
  • Bachelor’s degree in Biology, Microbiology or Biochemistry.
  • Master of Science degree preferred.
  • Knowledge of USP, EP, JP and FDA requirements.
  • Familiarity with applicable US and worldwide regulatory requirements for the Pharmaceutical/biopharmaceutical industry (i.e. GMP and GLP).
Job Preferences:
  • ASQ certified Auditor preferred.
  • ISO certified Auditor preferred.
  • Previous Quality Systems training.
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