QC Scientist I: Elevate GMP Lab Testing & Impact

Replimune; United Kingdom; Remote; GBP 42,000 - 56,000; Full time

Job summary

Replimune is seeking a QC Analyst to perform QC testing according to SOPs and cGMP, support the QC lab and junior staff at Milton Park. The role involves assay transfers, validation, and documentation review.

Based in the UK with on-site work expected five days a week, you will contribute to regulatory inspections and lead troubleshooting or method optimization as needed, with potential line management responsibilities.

Qualifications

• 4+ years of GLP/GMP experience in a relevant work environment.
• Computer literacy with MS Word and Excel.
• Effective communication and teamwork skills.
• Good organizational skills.

Responsibilities

• Perform QC testing following SOPs.
• Assist with maintenance of QC laboratory and equipment.
• Generate protocol and report for assay transfers/validation.
• Review and complete documentation per cGMP.
• Author and review SOPs, forms, deviations, CAPA, CoA reports.
• Lead or assist with OOS, OOT, and lab investigations.
• Participate in regulatory inspections and submissions.
• Lead QC lab equipment introduction and validation activities.
• Coordinate communicate QC requirements across functions.
• Manage receipt and storage of QC samples and reagents.
• Coordinate shipping of samples to Milton Park and contract labs.
• Train others in methods and processes per GMP.
• Become SME/Trainer for method/process, lead troubleshooting.
• Line management responsibility for direct reports if applicable.

Skills

GLP/GMP experience

Computer literacy

Communication skills

Teamwork

Organisational skills

Education

BA/BS in Chemistry/Biochemistry/Microbiology

Job description

Replimune is seeking a QC Analyst to perform QC testing according to SOPs and cGMP, support the QC lab and junior staff at Milton Park. The role involves assay transfers, validation, and documentation review.

Based in the UK with on-site work expected five days a week, you will contribute to regulatory inspections and lead troubleshooting or method optimization as needed, with potential line management responsibilities.