QC Analytical Scientist

22 hours ago


London, Greater London, United Kingdom X4 Life Sciences Full time £37,000 - £42,000
Job Title: QC Analytical Scientist

X4 Life Sciences is seeking a highly skilled QC Analytical Scientist to join their London-based team. The successful candidate will be responsible for testing gene therapy products and associated materials used for manufacturing to EU and FDA GMP requirements.

Key Responsibilities:
  • Testing of gene therapy products in accordance with product specifications to ensure all testing is completed within the required timelines in alignment with the production schedule.
  • Operation and maintenance of laboratory equipment ensuring all equipment is calibrated and suitable for use in alignment with the test schedule.
  • Record of out of specifications, non-conformances, investigations, analysis and implementation of corrective action(s) as applicable.
  • Part of the Quality Control team, maintain the flow of information, ensuring appropriate communications are passed and information folders are maintained with most recent version/communication.
  • Maintain QC facilities to meet GMP requirements, conduct necessary checks to support any health authority, customer/stakeholder site visits.
  • Support and external or internal audits where required.
Requirements:
  • Degree in Human Health or Sciences or equivalent relevant work experience in the pharmaceutical or other similar regulated industry (i.e biologics).
  • Demonstrated knowledge/experience of a GMP environment and quality control within a pharmaceutical or other regulated industry.
  • Proficiency in a body of information required for the job e.g. knowledge of EU and FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc.


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