Quality Control Manager

3 weeks ago

Abingdon, Oxfordshire, United Kingdom Replimune, Inc. Full time
Quality Control Specialist II

Replimune is revolutionizing cancer treatment with innovative therapies designed to activate a powerful and durable full-body anti-tumor response. We're seeking a Quality Control Specialist II to join our team and contribute to our mission to transform cancer care.

About the Role

This role is responsible for managing quality records within the Quality Control Group and ensuring the Quality Control group maintains a state of inspection readiness. The Quality Control Specialist II will have oversight of all quality records progressed by the Quality Control group and work with colleagues both within QC and other departments to ensure on-time closure of records.

Key Responsibilities
  • Maintain oversight of all quality records in Quality Control and ensure timely completion of records.
  • Participate in regulatory inspections and submissions.
  • Generate protocol and report for assay transfers/validation.
  • Review and complete documentation in accordance with current Good Manufacturing Practices (cGMP).
  • Author and review SOPs, forms, Deviations, Change controls CAPA, CoA (Certificate of Analysis) reports.
  • Lead or assist with OOS, OOT, and lab investigations as needed.
  • Lead QC laboratory equipment introduction and participate in validation activities.
  • Interact within internal as well as across other functional groups to communicate QC requirements.
  • Perform QC testing following Standard Operating Procedures (SOPs).
  • Assist with the maintenance of QC laboratory and equipment.
  • Manage receipt and storage of QC samples, reagents, and maintain retain inventory.
  • Coordinate shipping of samples to Milton Park and contract testing laboratories.
  • Training others within department for methods and processes according to GMP standards.
  • Become SME/Trainer for method or process and lead troubleshooting or method optimization as required.
  • Line management responsibility for direct reports if applicable.
Qualifications
  • Preferred Educational requirements: A BA or BS in Chemistry/Biochemistry/Microbiology or other related science.
  • Experience and skill requirement: 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.
  • Good organizational skills.
About Replimune

Replimune Group, Inc. is a biotechnology company headquartered in Woburn, MA, founded in 2015 with the mission to transform cancer treatment by pioneering the development of a novel portfolio of oncolytic immunotherapies. Our proprietary RPx platform is based on a potent HSV-1 backbone intended to maximize immunogenic cell death and the induction of a systemic anti-tumor immune response. We're committed to making a difference in the lives of patients, caregivers, and our employees.

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