QC Scientist I: GMP/GLP Lab Specialist

Replimune; Abingdon; On-site; GBP 42,000 - 52,000; Full time

Job summary

Replimune seeks a QC professional to oversee testing and compliance at our Milton Park site. You will perform QC testing per SOPs, maintain the lab, and generate validation reports. You will collaborate across teams to ensure CGMP compliance and support regulatory activities.

The role includes SOP authoring, Investigations, and training junior staff, with potential line management responsibilities. This on-site position emphasizes teamwork and rigorous quality control in a cutting-edge cancer

Qualifications

• Minimum 4 years of GLP/GMP experience in a relevant environment.
• Proficient computer skills including MS Word and Excel.
• Strong ability to work with others and communicate effectively.
• Solid organizational skills to manage documentation and activities.

Responsibilities

• Perform QC testing following SOPs and cGMP.
• Assist in maintaining QC laboratory and equipment.
• Generate protocols and reports for assay transfers/validation.
• Review documentation per cGMP requirements.
• Author and review SOPs, forms, deviations, CAPA, CoA reports.
• Lead or assist with OOS/OOT investigations as needed.
• Participate in regulatory inspections and submissions.
• Lead QC equipment introduction and validation activities.
• Coordinate with other groups to communicate QC needs.
• Manage receipt and storage of QC samples and reagents.
• Coordinate shipping of samples to Milton Park and external labs.
• Train others on methods and GMP processes; become SME.
• Line management responsibilities for direct reports if applicable.
• Undertake special studies with external partners.
• Represent QC in inter-department meetings and with vendors.

Skills

Effective communication

Organizational skills

Team collaboration

Computer literacy (MS Word & Excel)

Education

BA/BS in Chemistry/Biochemistry/Microbiology or related science

Job description

Replimune seeks a QC professional to oversee testing and compliance at our Milton Park site. You will perform QC testing per SOPs, maintain the lab, and generate validation reports. You will collaborate across teams to ensure CGMP compliance and support regulatory activities.

The role includes SOP authoring, Investigations, and training junior staff, with potential line management responsibilities. This on-site position emphasizes teamwork and rigorous quality control in a cutting-edge cancer