QC Specialist, Scientist II

6 hours ago

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

We are seeking a highly skilled Scientist II, Quality Control to join our team at Replimune, Inc. This role will be responsible for performing QC testing according to Standard Operating Procedures (SOPs) and current Good Manufacturing Practices (cGMP). The successful candidate will also oversee the work of more junior QC staff and assist with the setting up and maintaining systems for QC Analytical Laboratory.

Key Responsibilities

  • Establish, revise and maintain procedures for QC testing.
  • Maintain QC systems related to in-process, final drug product and stability samples.
  • Review testing data of other analysts.
  • Assist with the maintenance of QC laboratory and equipment.
  • Responsible for the protocol and report generation of assay transfers related to QC tests.
  • Perform QC testing of raw materials, in-process, water and product samples following Standard Operating Procedures (SOPs).
  • Review and complete documentation in accordance with current Good Manufacturing Practices (cGMP).
  • Responsible for change control and deviation related to QC operations.
  • Assist with audits and regulatory inspections, as needed.
  • Assist with QC laboratory equipment validation.
  • Interact within internal as well as across other functional groups to communicate QC requirements.
  • Oversee sampling and storage of QC samples and maintain retain inventory.
  • Coordinate shipping of samples to Milton Park and contract testing laboratories.

Requirements

  • A BA or BS in Chemistry/Biochemistry/Microbiology or other related science.
  • 3-5 years 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.

Location: Replimune, Inc.

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