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Quality Assurance Specialist

Marin Metro Area, CA

Posted: 08/20/2018 Job Type: Scientific Job Number: JN -082018-22355
DUTIES:
  • Perform QA review of production records and other documentation associated with production and release of Biological products per QA SOPs
  • Receive, control, scan and archive of completed manufacturing production records
  • Update QA databases for batch record review status
  • Prepare and compile batch record lot history files for Cell Culture or Formulated bulk drug substance (FBDS) lots.
  • Interact with Manufacturing personnel
  • Expected to exercise some independent judgment within the job responsibilities and perform the job responsibilities with minimum supervision.
  • Understand QA systems such as raw material disposition, deviations, and change control to ensure batch records are compliant with these systems.
SKILLS:
  • 0-2 years relevant experience
  • Working knowledge of desktop computers (ie: Excel, Microsoft Word).
EDUCATION:
  • Bachelor of Science degree in Biology, Biochemistry, Chemistry, Chemical Engineering or related field.

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