QUALIFICATIONS

• A degree in a life science, or relevant subject. A postgraduate qualification is desirable.

• An exciting opportunity for a Senior QC Analyst – Analytical to join our Quality team.
• You’ll be responsible for working with the development team on analytical assays for testing human embryonic stem cell lines and cell & gene therapies for human application.
• Identify area of improvement and lead process improvement projects within the department.
• Perform assimilation, statistical analysis, and interpretation of complex, multi-format data sets.
• Author, revise, and implement QC SOPs in alignment with regulatory guidelines.
• Lead root cause investigations into contamination events and deviations.
• Compile and report on analytical data to facilitate product release.
• Develop and deliver trend analyses and periodic summary reports for senior management, including QPs, and chair formal review meetings to drive data-driven improvements.
• Execute GMP documentation workflows within QC, including Incident Reports, Change Controls and Risk Assessments.
• Coordinate and perform QC batch release testing of advanced cellular therapy product
• Oversee day-to-day laboratory operations, ensuring adherence to cGMP, maintenance of QC systems, and operational excellence.