Senior Quality Control Specialist

3 days ago

London, Greater London, United Kingdom X4 Life Sciences Full time
Quality Control Specialist - Gene Therapy Products

X4 Life Sciences is collaborating with a pioneering Cell and Gene company to find a highly skilled Quality Control Specialist to join their London-based team. The successful candidate will be responsible for ensuring the quality of gene therapy products and associated materials used for manufacturing, in accordance with EU and FDA GMP requirements.

Key Responsibilities:

  • Conduct testing of gene therapy products to ensure compliance with product specifications and production schedules.
  • Operate and maintain laboratory equipment, ensuring calibration and suitability for use.
  • Record and investigate out-of-specifications, non-conformances, and implement corrective actions as necessary.
  • Collaborate with the Quality Control team to maintain accurate records and ensure effective communication.
  • Maintain QC facilities to meet GMP requirements and support health authority, customer, and stakeholder site visits.
  • Support internal and external audits as required.

Requirements:

  • Degree in Human Health or Sciences or equivalent relevant work experience in the pharmaceutical or regulated industry.
  • Demonstrated knowledge of GMP environments and quality control within a pharmaceutical or regulated industry.
  • Proficiency in EU and FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, and other relevant areas.

X4 Life Sciences is committed to finding the right candidate for this role. If you are a motivated and experienced Quality Control Specialist, please submit your CV for consideration.

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