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QC Analytical Scientist
2 months ago
X4 Life Sciences is seeking a highly skilled QC Analytical Scientist to join our team in London. As a key member of our Quality Control team, you will be responsible for ensuring the testing of gene therapy products and associated materials meets EU and FDA GMP requirements.
Key Responsibilities- Testing and Quality Control: Conduct testing of gene therapy products in accordance with product specifications, ensuring all testing is completed within required timelines and aligned with the production schedule.
- Laboratory Equipment Maintenance: Operate and maintain laboratory equipment, ensuring all equipment is calibrated and suitable for use in alignment with the test schedule.
- Record Keeping and Compliance: Maintain accurate records of out-of-specifications, non-conformances, investigations, analysis, and implementation of corrective actions as applicable.
- Quality Control Team Collaboration: Work closely with the Quality Control team to maintain the flow of information, ensuring appropriate communications are passed and information folders are up-to-date.
- GMP Compliance: Maintain QC facilities to meet GMP requirements, conduct necessary checks to support health authority, customer, and stakeholder site visits.
- Audit Support: Support internal and external audits as required.
- Education and Experience: Degree in Human Health or Sciences or equivalent relevant work experience in the pharmaceutical or other regulated industry.
- GMP Knowledge and Experience: Demonstrated knowledge and experience of a GMP environment and quality control within a pharmaceutical or other regulated industry.
- Regulatory Knowledge: Proficiency in EU and FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, and other relevant regulatory requirements.
