QA Associate

Bothell, Washington
Industry: QA Testers
Job Number: JN -052021-63536

Purpose and scope of position:

  • The QSAT (Quality Science and Technology) team is responsible for overseeing and supporting the management of deviation and CAPA records through the electronic quality record management system at the Manufacturing Plant located in Bothell, WA. The QSAT Deviation Reviewer/Approver is an individual contributor role responsible for the review and approval of events classified as Notice of Event-Only and Minor deviations. 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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