Senior Quality Control Analyst - Analytical

at  RoslinCT

QUALIFICATIONS

• A degree in a life science subject or equivalent qualification and experience is required.
• A post-graduate qualification is desirable.

• Develop assays appropriate for Characterisation and Safety testing of human embryonic stem cell lines and cell and gene therapies for human application.
• Assimilation, manipulation, and accurate interpretation of complex data sets in many forms.
• Routine QC testing of cell and gene therapies to a GMP standard.
• Review and update current QC SOPs and establishing new SOPs.
• Training and certification of all personnel carrying out analytical activities. This role may include line management of some team members.
• Ensure that all processes are subjected to appropriate levels of analytical sampling and review.
• Lead investigations on incidents of product contaminations.
• Compiling and reporting of all analytical data to facilitate product release.
• Review current regulatory requirements to ensure ongoing compliance.
• Develop the Analytical laboratory by identifying trends and new technologies and bringing them in-house.
• Validate new techniques and processes and training of others in these methods.
• Validation of equipment and maintaining calibration and servicing records.
• Generate trend and summary reports for the benefit of RoslinCT management, including QPs, and chairing regular review meetings.
• Support QC batch release of cellular therapy products by performing and co-ordinating QC batch release testing as required.
• Participate in the day to day running of the QC laboratories to ensure a high standard of organisation is always observed.
• Write and approve Standard Operating Procedures, as well as documentation review and sign off (where appropriate).
• Completion of GMP documentation within the QC department including, Incident Reports, Change Controls and Risk Assessments.
• Provide out of hours cover for critical equipment alarms as required on a rotational basis.