Job Description

Position Description:


Responsible for QA oversight on the floor of all GMP Manufacturing processes. This role involves conduction real time quality inspections and collaborating with the production team to understand and resolve quality concerns immediately on the floor. The QA Floor Associate is essential for maintaining GMP compliance and providing support to Parenteral Manufacturing.

Key Objectives /Deliverables:

  • Ensure regular presence in operational areas to monitor GMP programs and quality systems including various production activities such as drug product formulation, equipment preparation and aseptic filling activity.

  • Review batch records in real time to ensure adherence to standard operation procedures.

  • Collaborate closely with process teams to resolve quality issues and operational support.

  • Ability to complete gowning qualification.

  • Ensure data integrity by design.

    • Additional...

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