Senior Quality Control Analyst

Role overview

Key responsibilities

• Test routine and non-routine QC samples according to SOPs and established methods; maintain cell lines by revival and passaging.
• Receive QC samples and materials, maintain inventory, and perform routine equipment maintenance and troubleshooting.
• Lead introduction of new equipment and participate in validation activities.
• Write, update or review SOPs, protocols and forms; participate in method transfers, validation and stability activities.
• Follow cGMP and GDP; complete laboratory housekeeping, monitor and order supplies, and keep training GMP-compliant.
• Write deviations, CAPAs and change controls and assist investigations into OOS and OOT results.
• Train junior team members in methods and processes and assist with internal and regulatory audits and inspections.

Education and experience

• Degree in Chemistry, Biochemistry or another related science.
• At least three years of laboratory-based experience in a similar environment.
• Understanding of GMP requirements.
• Analytical ability, attention to detail, computer literacy including MS Word and Excel, and good communication and organizational skills.
• Ability to work independently and with a team.

Workplace

• Based at Milton Park with a typical five-day on-site expectation.

About Replimune