QA Validation Specialist
Posted 2 days ago by Skills Alliance Enterprise
Negotiable
Undetermined
Undetermined
Stevenage, England, United Kingdom
Summary: Our client is seeking a Quality Assurance professional to support the delivery of autologous CAR T-cell products for commercial and clinical use across the UK, EU, and US. This role involves maintaining GMP compliance, collaborating with cross-functional teams, and ensuring high-quality support within the central GMP manufacturing site’s QA team. The position emphasizes continuous improvement and adherence to regulatory standards while fostering a collaborative work environment. Employees benefit from flexible working options and a comprehensive benefits package.
Key Responsibilities:
- Maintain GMP compliance within a multi-product facility supporting cell and gene therapy manufacturing.
- Collaborate with cross-functional teams to uphold cGMP standards.
- Review and approve validation documentation; escalate quality concerns as needed.
- Ensure compliance within Validation, including periodic review of VMP trackers.
- Author, review, and approve GxP documentation.
- Act as a QA representative supporting the Pharmaceutical Quality System (PQS), including oversight of change controls, deviations, complaints, QC invalids, OOT/OOS results, and environmental excursions.
- Collate, trend, and report Quality KPIs.
- Conduct periodic quality reviews for non-complex GxP systems.
- Provide updates, progress, and issue escalation to QA management.
- Contribute to continuous improvement initiatives within the PQS.
- Act as QA representative/SME for small projects; support larger projects under supervision.
- Assist with training and development of team members.
- Adhere to all local Health & Safety policies and SOPs.
- Perform additional duties as assigned.
- Serve as QA representative for QMS records supporting broader business needs.
- Provide support during regulatory and internal inspections.
Key Skills:
- 1–2 years of experience in pharmaceutical/biotech quality assurance or a similar regulated environment.
- Ability to meet cleanroom entry requirements.
- BSc in pharmaceutical sciences, immunology, biology, chemistry, or a related field.
- Strong understanding of GMP principles.
- Familiarity with GCP principles.
- Strong communication skills and ability to collaborate effectively across teams.
- Ability to build strong cross-functional relationships.
- High attention to detail and accuracy in documentation.
- Strong prioritization, time-management, and decision-making skills.
- Reliable, flexible, and team-oriented mindset.
- Ability to manage multiple activities and meet tight deadlines.
Salary (Rate): undetermined
City: Stevenage
Country: United Kingdom
Working Arrangements: undetermined
IR35 Status: undetermined
Seniority Level: undetermined
Industry: Other
Our client is driven by the pursuit of excellence and the mission to push the boundaries of cancer therapy. They are dedicated to delivering life-changing treatments to patients worldwide. Employees enjoy a flexible, diverse, and collaborative work environment that encourages creativity, leadership, and teamwork. The organization offers a competitive salary, performance-based bonus, comprehensive medical benefits, life insurance, pension contributions, and participation in an employee share program. Flexible working options are supported.
Role Summary
Our client is seeking a Quality Assurance professional to support the delivery of autologous CAR T-cell products for commercial and clinical use across the UK, EU, and US. This role is part of the central GMP manufacturing site’s QA team and will collaborate closely with internal stakeholders to ensure high-quality support and compliant operations.
Primary Responsibilities
- Maintain GMP compliance within a multi-product facility supporting cell and gene therapy manufacturing.
- Collaborate with cross-functional teams to uphold cGMP standards.
- Review and approve validation documentation; escalate quality concerns as needed.
- Ensure compliance within Validation, including periodic review of VMP trackers.
- Author, review, and approve GxP documentation.
- Act as a QA representative supporting the Pharmaceutical Quality System (PQS), including oversight of change controls, deviations, complaints, QC invalids, OOT/OOS results, and environmental excursions.
- Collate, trend, and report Quality KPIs.
- Conduct periodic quality reviews for non-complex GxP systems.
- Provide updates, progress, and issue escalation to QA management.
- Contribute to continuous improvement initiatives within the PQS.
- Act as QA representative/SME for small projects; support larger projects under supervision.
- Assist with training and development of team members.
- Adhere to all local Health & Safety policies and SOPs.
- Perform additional duties as assigned.
Secondary Responsibilities
- Serve as QA representative for QMS records supporting broader business needs.
- Provide support during regulatory and internal inspections.
Required & Preferred Qualifications
Experience
- 1–2 years of experience in pharmaceutical/biotech quality assurance or a similar regulated environment (E).
Ability to meet cleanroom entry requirements (P).
Education
- BSc in pharmaceutical sciences, immunology, biology, chemistry, or a related field (E).
Skills & Knowledge
- Strong understanding of GMP principles (E).
- Familiarity with GCP principles (P).
- Strong communication skills and ability to collaborate effectively across teams.
- Ability to build strong cross-functional relationships.
- High attention to detail and accuracy in documentation.
- Strong prioritization, time-management, and decision-making skills.
- Reliable, flexible, and team-oriented mindset.
- Ability to manage multiple activities and meet tight deadlines.