Quality Assurance Associate (12‑month contract)

About the role

This 12‑month contract position supports the Quality Assurance function within a GMP‑regulated environment. You will provide oversight for a range of studies and activities, ensuring compliance with regulatory expectations and driving continuous improvement across Development Services and QC.

Key responsibilities

• Review and approve deviations, CAPAs, change controls, investigations and OOS records.
• Assess QA activities for MSAT, pilot and Development Services studies.
• Evaluate QC outputs including method validation, reference standards and stability studies.
• Manage critical compliance issues through the QMS and conduct audit‑trail reviews.
• Perform area walkthroughs, audit raw data, protocols and validation reports for GMP compliance.
• Lead process audits, support GMP audit activities and maintain audit readiness.
• Provide QA SME support to Operations, QC, MSAT and Development Services, mentoring partners in GMP practices.
• Participate in continuous‑improvement initiatives and local quality councils.

Required profile

• Advanced degree in a scientific discipline.
• 5‑10 years of QA or QC experience in a GMP‑regulated manufacturing environment.
• Proven experience with TrackWise (deviations, change controls, CAPA, investigations).
• Hands‑on experience with OOS investigations and audit activities.
• Strong understanding of GMP requirements and regulatory authority expectations.

Required skills

• TrackWise
• GMP
• CAPA
• OOS investigations
• Audit

What we offer

• Fixed‑term 12‑month contract based in Slough.
• Pay rate up to £32.76 per hour, DOE.
• Opportunity to work within a collaborative, quality‑focused team.