Senior QA Specialist, GMP Cell Therapy | 12-Month Contract

RBW Consulting; England; On-site; GBP 55,000 - 75,000; Full time

Benefits offered by this job

Competitive salary

Job summary

RBW Consulting in Hertfordshire is seeking a Senior QA Specialist for a 12-month contract within a cutting-edge biotechnology environment developing life-changing therapies. You will provide quality oversight in a GMP-regulated manufacturing setting, supporting the production and release of cell and gene therapy products.

You will review batch records, deviations, CAPAs and change controls; work with Manufacturing, QC, Validation and Regulatory teams; contribute to inspection readiness and

Qualifications

• Experience in Pharmaceutical/Biotech/ATMP or cell therapy environments.
• Strong GMP quality systems and regulatory compliance knowledge.
• Experience in sterile/aseptic manufacturing environments.
• Proven track record in managing deviations, CAPAs, change controls.
• Excellent stakeholder management and communication skills.

Responsibilities

• QA support for GMP manufacturing operations in sterile production.
• Review and approve batch records, deviations, CAPAs, change controls, GMP docs.
• Support investigations, risk assessments, supplier quality activities, audits.
• Collaborate with Manufacturing, QC, Validation, Regulatory to ensure compliance.
• Contribute to inspection readiness and continuous improvement.

Skills

QA oversight

GMP knowledge

Regulatory compliance

Stakeholder management

Quality investigations

Tools

CAPA management

Deviation handling

Change control

Job description

RBW Consulting in Hertfordshire is seeking a Senior QA Specialist for a 12-month contract within a cutting-edge biotechnology environment developing life-changing therapies. You will provide quality oversight in a GMP-regulated manufacturing setting, supporting the production and release of cell and gene therapy products.

You will review batch records, deviations, CAPAs and change controls; work with Manufacturing, QC, Validation and Regulatory teams; contribute to inspection readiness and