Quality Assurance Specialist-CMC
Exton, PA (Research)
Responsible for ensuring the implementation of the quality system for the CMC services department analytical services laboratory and CTM manufacturing. Complies with all relevant cGMP/GLP regulatory requirements while carrying out assigned tasks.
Review and preparation of new and revised Standard Operating Procedures associated with the functions of the Analytical Testing and the Clinical Trial Material (CTM) divisions of CMC Services.
- Perform review of analytical documents, checking for compliance with Good Documentation Practices (GDPs), Good Manufacturing Practices (GMPs), and any other relevant standards.
- Provide prompt and thorough feedback to author as needed, to ensure that compliance requirements are understood and met.
- Perform similar review for analytical documents performed according to Good Laboratory Practices (GLPs) as required.
- Sample incoming raw materials for GMP use.
- Inspect and release the CTM rooms, materials, records needed prior to manufacture.
- Perform CTM Product Release, based upon the established requirements.
- Conduct Internal Audits of Manufacturing, Packaging and Labeling and Analytical areas, as required.
- Participate in External Audits by preparing and presenting documentation relevant to audit scope.
- Assist with Training Program; conduct training sessions on GMP compliance for laboratory and manufacturing personnel.
- Oversee and coordinate analytical laboratory and CTM equipment qualification documents.
- Attend client meetings as required, to provide QA input and support.
- Other duties as required
- Bachelor’s degree in Chemistry, Biology, or related discipline (QA/RA), with at least 5 years relevant experience in the pharmaceutical or related industry.