iSixSigma

QA Deviation Reviewer/Approver

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SSI
Published
June 9, 2021
Location
Bothell, WA
Job Type

Description

Management of deviation and CAPA records will include:

  • cross-functional collaboration to ensure the proper root cause and corrective actions have been identified
  • ensuring the written report contains the technical merit and completeness according to regulatory expectations
  • coaching customers on navigation within the deviation management electronic system

Education:

  • Bachelor or Master s degree in Life Science or Engineering discipline.

Experience

  • 3+ years of experience in execution and/or approval of deviation investigations.
  • Experience and knowledge of cGMPs and applicable FDA/EMA regulations in the biotechnology / pharmaceutical industry; experience in protein biologics or cellular therapy field is preferred.
  • Experience in a Quality Assurance or technical MSAT role within a GMP manufacturing organization.
  • Experience with using Root Cause Analysis (RCA) tools and methodologies.
  • Experience with using Quality Risk Management principles.
  • Experience with use of complex research techniques and methodologies like six sigma and Kaizen to improve process/product quality is a plus.
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