Senior QA Specialist I

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

Senior QA Specialist Hertfordshire 12-Month Contract | Competitive Salary

Are you an experienced QA professional looking to join a cutting-edge biotechnology environment developing life-changing advanced therapies? We are seeking a Senior QA Specialist to provide quality oversight within a GMP-regulated manufacturing environment, supporting the production and release of innovative cell and gene therapy products.

Key Responsibilities

• Provide QA support for GMP manufacturing operations within a sterile production environment.
• Review and approve batch records, deviations, CAPAs, change controls, and GMP documentation.
• Support investigations, quality risk assessments, supplier quality activities, and audit programmes.
• Work closely with Manufacturing, QC, Validation, and Regulatory teams to ensure compliance and product quality.
• Contribute to inspection readiness and continuous improvement initiatives.

Requirements

• Experience within Pharmaceutical, Biotech, Cell Therapy, Gene Therapy, or ATMP environments.
• Strong knowledge of GMP quality systems and regulatory compliance.
• Experience within sterile and/or aseptic manufacturing environments is essential.
• Proven experience managing deviations, CAPAs, change controls, investigations, and batch documentation.
• Strong stakeholder management and communication skills.

What's on Offer?

• Opportunity to work with pioneering advanced therapy products.
• Exposure to a highly innovative GMP manufacturing environment.
• Collaborative and fast-paced culture.
• Competitive salary and comprehensive benefits package.
• 12-month contract offering the opportunity to make a significant impact within a growing organisation.