GMP Batch Review Associate (Temp)

RoslinCT; City of Edinburgh; On-site; GBP 28,000 - 38,000; Full time

Benefits offered by this job

Annual leave 31 days

Public holidays 4

Pension scheme

Group life cover

Private healthcare

Flexible benefits

Job summary

RoslinCT is seeking a Manufacturing Batch Reviewer I to join the MBRT in Edinburgh BioQuarter. The role focuses on reviewing batch records, environmental monitoring, and related data to ensure GMP compliance and adherence to SOPs. It involves collaboration with Manufacturing and Quality teams to address issues.

The position is temporary (Oct 2026–Apr 2027) and offers a competitive salary package, enhanced leave, and private healthcare as part of a comprehensive benefits program.

Qualifications

• Background in stem cells, gene or cell therapies or cell banking.
• Knowledge of cGMP incl. aseptic processing, documentation and record management.
• Experience following SOPs and maintaining high compliance.
• Skilled in technical writing and addressing GMP audit findings.

Responsibilities

• Review manufacturing batch documentation (batch records, in-process data and environmental monitoring) for GMP compliance.
• Investigate and assess technical problems identified during reviews with Manufacturing and Quality teams.
• Communicate quality events and raise deviations as needed.
• Generate environmental monitoring reports and investigate discrepancies.
• Input batch data into analytics software for CPV.
• Provide feedback on findings to relevant departments during reviews.
• Identify trends and drive improvement to reduce data errors and deviations.
• Support timely closure of packs for batch disposition and shipment to patients.

Skills

Attention to detail

Strong planning

Communication skills

Organisational skills

Interpersonal skills

Technical writing

Regulatory knowledge

Education

BSc in Life Science

Tools

Microsoft Excel

Document management systems

CPV software

Job description

RoslinCT is seeking a Manufacturing Batch Reviewer I to join the MBRT in Edinburgh BioQuarter. The role focuses on reviewing batch records, environmental monitoring, and related data to ensure GMP compliance and adherence to SOPs. It involves collaboration with Manufacturing and Quality teams to address issues.

The position is temporary (Oct 2026–Apr 2027) and offers a competitive salary package, enhanced leave, and private healthcare as part of a comprehensive benefits program.