Quality Assurance Specialist- Pharmaceutical manufacturing

1 month ago


Novato, United States Intelliswift Software Full time

Job Title - Quality Assurance Specialist- Pharmaceutical manufacturing

Location – Novato, CA

Duration: 12 months

Responsibilities

  • This position reports to the Quality Assurance Supervisor/ Manager/ Senior Manager and is responsible for quality oversight of one or more processes relating to make, assess, and release for products produced in Novato manufacturing facilities.
  • The responsibilities in the role include the following:
  • Provide quality oversight of one or more portions of operations including, but not limited to;
  • Direct observation of manufacturing operation for adherence to GMP.
  • Review of GMP documentation from manufacturing and/ or QC, which can include log books, batch records and test records.
  • Issuance of Production Batch Record to Manufacturing
  • Scanning and archiving executed production batch records
  • Ensure manufacturing and QC adherence to company policies/procedures, regulatory licenses, industry standards, and GMP regulations. Working knowledge of United States and European regulatory requirements, guidelines, and recommendations a plus (additional jurisdictions a plus).
  • Revise QA related procedures as needed.
  • Attention to detail. MS Office. Ability to operate basic office equipment, e.g. scanners, printers.



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