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Quality Assurance Lead

2 months ago

Seattle, Washington, United States EPM Scientific Full time

Position: Quality Control Manager

Location: Hybrid

We are seeking a skilled professional to oversee quality control processes within a dynamic cell therapy organization specializing in T-cell therapies aimed at treating autoimmune and degenerative conditions. This position is crucial for ensuring the quality and compliance of our products and will report directly to the Quality Assurance department.

Primary Responsibilities:

  • Oversee the management of in-process, release, and stability quality control data for both raw materials and finished products.
  • Set project timelines, conduct thorough reviews of content, and offer expertise in quality and compliance matters.
  • Facilitate method transfers, method validations, and ensure the integrity of analytical data.
  • Direct and manage timelines for deviations, investigations, corrective and preventive actions (CAPAs), and change controls.
  • Foster and maintain effective relationships with both internal teams and external partners.

Qualifications:

  • Proven experience in the biotech or pharmaceutical sector, with a focus on cell therapy.
  • Demonstrated management experience within quality control.
  • In-depth knowledge of CAPAs, deviations, change controls, investigations, out-of-specification (OOS), and out-of-trend (OOT) processes.
  • Strong background in microbiology, quantitative PCR (qPCR), flow cytometry, enzyme-linked immunosorbent assay (ELISA), and cell-based assays.