Senior QC Analyst - Analytical
- Edinburgh
- Permanent
- Full-time
- The opportunity to join a rapidly expanding company which is changing lives, giving you the skills and experience to develop your career.
- A generous salary package – we reward our people at the level they deserve.
- 31 days of annual leave, plus 4 public holidays which increases with tenure.
- A competitive company pension scheme to help you save for the future.
- Group Life Cover – you are automatically covered for three times your basic salary to give you and your family peace of mind.
- Private healthcare and access to mental health/wellbeing support as your health and wellbeing means a lot to us.
- Flexible benefits such as retail discounts and access to the Cycle2Work scheme.
- 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.
- Prior experience working in a GMP Quality Control molecular biology / analytical laboratory, with commercial experience.
- Experience in assay validation, stability testing, tissue culture, QC product testing and writing procedures to meet GMP and ICH guidelines.
- Experience in a variety of laboratory activities, with specialist knowledge of Flow Cytometry.
- Working knowledge of UK laws and regulations for cell therapy products and tissue donation.
- Excellent verbal communication skills, with the ability to effectively manage and influence stakeholders’ and customer expectations.
- Exceptional written communication skills, with a good standard of written English to support writing reports accurately and clearly.
- Good organisational and planning skills with the ability to multi-task in a fast-paced environment.
- A degree in a life science, or relevant subject. A postgraduate qualification is desirable.