Senior Quality Control Analyst

Summary of job description:

The role is responsible for performing the routine and non-routine QC testing following Standard Operating Procedures (SOPs) and established test methods, conduct laboratory-based activities such as reagent preparation, tissue culture, equipment maintenance, sample receipt and disposal etc. It also involves other QC tasks such as maintaining sample/reagent/consumable inventory and ordering reagents, writing and updating documents, supporting transfer of new methods and supporting audits and inspections.

This position is based in our Milton Park location and typically has a 5-day on-site expectation

Key responsibilities:

· Perform QC testing of various routine and non-routine samples according to Standard Operating Procedures (SOPs).

· Maintain various cell lines on regular basis by revival and passaging at set intervals.

· Perform QC sample and material receipt and maintain inventory.

· Routine equipment maintenance and troubleshooting as required.

· Lead introduction of new equipment and participate in validation activities.

· Write, update or review SOPs, protocols, FORMs and update as required.

· Participate in QC method transfers, validation, and stability activities.

· Adhere to current Good Manufacturing Practices (cGMP) and Good Documentation practices (GDP).

· General lab tasks such as housekeeping, inventory of supplies, order supplies etc.

· Write deviations/CAPA/Change controls related to QC and assist with investigations related to OOS and OOT results.

· Become a trainer in method as processes and train junior member of the team as required.

· Assist with internal and regulatory agency audits / inspections.

· Ensure training is kept in GMP compliant state.

Educational Requirements:

· Degree in Chemistry/Biochemistry/ other related science.

Experience and Skill Requirements:

· 3 years or more of laboratory-based experience working in similar environment.

· Competent analytical skills and attention for details.

· Understanding of GMP requirements

· Computer literacy (including MS Word and Excel), good communication and organizational skills.

· Ability to work independently and with others in a team