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Compliance Specialist IIIBerks County, PA
Compliance Specialist III, Pennsylvania, USA
PharmEng Technology is currently looking for a Compliance Specialist III for a client site in PA.
- 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.
- 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).
- ASQ certified Auditor preferred.
- ISO certified Auditor preferred.
- Previous Quality Systems training.