Specialist, Deviations Investigator – Boulder, CO

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Support cGMP manufacturing operations for manufactured biopharmaceutical products. Responsibilities include:

  • Lead Deviation Investigations
  • Collect information, Review documentation, Conduct interviews, Perform Root Cause Analysis, Determine Product Impact, Identify CAPA(s), and Author deviation investigation reports.
  • Lead CAPA implementation as applicable.
  • Generate, revise, and review of standard operating procedures (SOP’s) for process equipment and procedures used for production operations.
  • Maintain records to comply with regulatory requirements and cGMPs.
  • Interface effectively with management personnel across Manufacturing, Quality,…
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