Cell Therapy QA Specialist

3 weeks ago


Raritan, New Jersey, United States Legend Biotech US Full time
Job Summary

We are seeking a highly skilled Cell Therapy QA Specialist to join our Quality Operations team based in Raritan, New Jersey.

Key Responsibilities
  1. Provide quality oversight of all aspects of the cell therapy clinical manufacturing process.
  2. Supervise manufacturing and manufacturing support activities for cGMP compliance through spot checks/internal audits.
  3. Collaborate with site personnel to provide guidance and determine immediate path forward for manufacturing issues.
  4. Review, revise, or draft Standard Operating Procedures (SOPs).
  5. Support on process aseptic process simulations of the processes to ensure sterility of the product/process is not compromised.
  6. Support material release in SAP for In-house reagents.
  7. Strive to reduce non-conformances in supported areas by proactively driving compliance.
  8. Support Investigations team by providing quality and compliance input for continuous improvement and remediations.
  9. Serve as a backup for approving printed labels and documents prior to use on the manufacturing floor.
  10. Utilize multiple electronic quality systems, batch records and SAP.
Requirements
  • Bachelors degree required in Life Sciences or Engineering.
  • 0-2+ years Biotech/Pharmaceutical experience or equivalent industry experience.
  • Must have relevant working experience in an aseptic manufacturing facility, preferably in quality assurance, manufacturing compliance, clinical quality, technical operations or cell therapy.
  • Experience with quality support in clinical manufacture is preferred.


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