Sr. Analyst, Quality Control

Replimune Group

Replimune Group

IT, Quality Assurance
Abingdon, UK
Posted on Tuesday, May 14, 2024

Sr. Analyst, Quality Control

Job Locations UK-Oxfordshire-Abingdon
ID
2024-1483
Category
Hidden (8748)
Position Type
Regular Full-Time

Overview

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 Milton Park and requires a 5 day presence in the office.

Responsibilities

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.

Qualifications

Education

  • 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

UK Location: Please note that there is a 5 day a week onsite expectation

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