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Quality Assurance Associate, Lot Release (Tuesday – Saturday)

SUMMARY

The Quality Assurance Associate will provide support for all drug product lots manufactured for Adaptimmune LLC. Following Adaptimmune Quality Policies and Procedures, the Quality Assurances Associate will be responsible for issuing batch labels, performing daily line clearance activities in the clean room suites, and reviewing executed batch records and QC data. The Quality Assurance Associate will also be responsible for the receipt and shipment of patient material and support the release of raw material for GMP manufacturing.

 

KEY RESPONSIBILITIES

  • Perform line clearance activities, on the floor audits and issue batch labels.
  • Review media batch records, production batch records, QC data and patient specific documentation to ensure the drug product meets acceptable quality attributes for release.
  • Receive/inspect incoming patient material and support shipments of final drug product.
  • Support the release of incoming raw material to ensure material meet specification prior to release for use in GMP manufacturing.
  • Opens deviations and investigations as appropriate based on Adaptimmune CMC and/or CMO notification.
  • Work with CMOS/CTLs to ensure timely delivery of documentation/materials.
  • Participate in and assist with weekly Batch Record Review and Lot Release Meeting to ensure timely release of drug product lots.

 

QUALIFICATIONS & EXPERIENCE

  • Minimum of 1-2 years in a global biopharmaceutical or biological manufacturing environment with exposure to Quality GMP operations.
  • Bachelor’s Degree in a scientific discipline preferred.
  • Solid technical writing skills related to investigation reports.
  • Broad knowledge of GMP, ICH and FDA/EMA regulations
  • Previous gowning experience in an aseptic environment
  • Excellent written and verbal skills
  • Ability to work and communicate internally and externally
  • Strong attention to detail
  • Able to manage multiple priorities
  • Excellent problem-solving skills
  • Able to exercise judgment to determine appropriate corrective actions
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