3256

Quality Assurance Specialist-CMC

Quality Assurance Specialist-CMC

Exton, PA (Research)

Summary:

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.

Responsibilities: 

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

Requirements:

  • Bachelor’s degree in Chemistry, Biology, or related discipline (QA/RA), with at least 5 years relevant experience in the pharmaceutical or related industry.

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