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QA Operations Associate

2 months ago

Novato, United States TalentBurst Full time
QA Operations Associate
Novato, CA
03+ Months

Provide quality oversight of one or more portions of operations including, but not limited to:
  • Review of GMP documentation from manufacturing, which can include but is not limited to logbooks, production batch records and electronic buffer & media batch records.
  • Scanning and archiving executed production batch records.
  • Ensure manufacturing 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).
  • Perform other duties and projects as assigned by management.
  • Production and batch records experience highly desired
Skills:
Attention to detail. GDP understanding required. Microsoft Office. Oracle EBS. Ability to operate basic office equipment (e.g., scanners, printers). SQL, as a plus.

Education:
Associate degree or higher.

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