QC Laboratory Lead

1 month ago


Abingdon, Oxfordshire, United Kingdom Replimune, Inc. Full time

As a Quality Control Specialist at Replimune, Inc., you will play a critical role in ensuring the quality of our products. Your primary responsibility will be to perform QC testing according to Standard Operating Procedures (SOPs) and current Good Manufacturing Practices (cGMP). You will also be responsible for managing the QC laboratory, including maintaining equipment and generating protocols and reports for assay transfers/validation. Additionally, you will review and complete documentation in accordance with cGMP and author SOPs, forms, Deviations, Change controls CAPA, CoA reports. You will also lead or assist with OOS, OOT, and lab investigations as needed and participate in regulatory inspections and submissions, as needed. Furthermore, you will lead QC laboratory equipment introduction and participate in validation activities, interact within internal as well as across other functional groups to communicate QC requirements, manage receipt and storage of QC samples, reagents and maintain retain inventory, coordinate shipping of samples to contract testing laboratories, train others within the department for methods and processes according to GMP standards, become SME/Trainer for method or process and lead troubleshooting or method optimization as required, and line management responsibility for direct reports if applicable. Preferred qualifications include a BA or BS in Chemistry/Biochemistry/Microbiology or other related science, 4 years or more GLP/GMP experience in a relevant work environment, computer literacy (including MS Word and Excel), ability to work well with others, effective communication skills, and good organizational skills. This position is based in our Milton Park location and typically has a 5-day on-site expectation.



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