Senior Quality Assurance Specialist

Senior Quality Control Specialist (Senior QC)

Location: Oxford, UK

Department: Quality, Quality Control

Reporting to: Manager, Quality

Type: Full-time, permanent

About the role

We are looking for a Senior Quality Control Specialist to join our Quality Control team based in Oxford. This is a hands‑on senior laboratory role with strong quality system ownership. You will lead day‑to‑day QC activities, act as a subject‑matter expert for methods, products and equipment, and drive high standards in cGMP compliance, data integrity and right‑first‑time documentation.

You will support routine testing (incoming materials and finished products) and contribute to new product development work where required, helping assess physical and chemical properties and their impact on final products.

Key responsibilities QC operations and delivery

• Lead the running of QC laboratory activities, plan workloads, balance priorities and ensure on‑time testing and documentation.
• Generate high‑quality results and documents within agreed timelines, using approved procedures and validated systems.

Technical leadership and compliance

• Act as SME for assigned methods, products and equipment; provide guidance on execution, troubleshooting and suitability.
• Ensure activities comply with cGMP, data integrity principles, Summit procedures and VMD ManSA requirements.
• Approve or author controlled documents within delegated authority, including SOPs, test methods, specifications, logbooks, CoAs and quality reports.

Quality system ownership, end‑to‑end

• Lead deviations and incidents; perform root‑cause analysis, risk assessments, CAPA definition and implementation, effectiveness checks and on‑time closure.
• Lead OOS, OOT and laboratory investigation work; coordinate testing and ensure compliant conclusions and narratives.
• Own CAPA and change controls related to methods, equipment, materials and processes; complete impact assessments, coordinate validation and training, implement and close changes.

Training, coaching and leadership

• Lead onboarding and ongoing training for QC personnel, build training matrices, assess competence and coach analysts in technique and documentation.
• Deliver refresher training on cGMP, data integrity and investigation quality, tailored to trends and audit findings.

Validation, equipment and audits

• Support or lead method verification and validation work, including protocol review, execution, data review and reporting.
• Oversee equipment qualification and maintenance activities (IQ, OQ, PQ), calibration, PM and out‑of‑service controls where required.
• Host and support internal, external and regulatory audits/inspections; present data clearly and own responses and follow‑ups.

What we’re looking for Essential

• Degree (or equivalent) in a science discipline.
• Strong experience in a cGMP QC laboratory environment, with the ability to work independently and make sound decisions with minimal supervision.
• Excellent knowledge of Good Manufacturing Practice and Good Documentation Practice, with a clear commitment to data integrity.
• Proven capability leading investigations (deviations, OOS/OOT) and delivering effective CAPAs and risk assessments.
• Strong communication skills; clear, timely written and verbal communication appropriate to the audience.
• Strong planning and organisation, able to prioritise shifting workloads and deliver to deadlines.

Desirable

• Working knowledge of Waters Empower (HPLC), plus broader chromatography experience.
• Experience supporting method validation/verification and equipment qualification activities.
• Audit hosting experience, and confidence presenting QC data and investigation narratives.

What we offer

• Competitive salary, dependent on experience.
• Competitive contributory pension and a comprehensive benefits package.
• A varied role with real ownership, impact and development opportunities within Quality and across the business.

How to apply

If you are interested in this role, please send an updated CV and a short note highlighting your relevant QC experience.

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