Quality Assurance Operations Specialist

1 month ago


Novato, United States Compass Consulting Full time

Our client focuses on developing first-in-class and best-in-class therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases.


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 their manufacturing facilities.
  • 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.


Qualifications:

  • Associates Degree required, Bachelor's Degree preferred
  • Attention to detail
  • MS Office
  • Ability to operate basic office equipment


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