Quality Assurance Specialist

About the role

The Quality Assurance Specialist will develop and implement a QA strategy and lead QA activities within a GMP‑regulated QC testing laboratory. The role ensures all laboratory operations, equipment and computerized systems meet regulatory standards, company procedures and client requirements.

Key responsibilities

• Develop and implement a new QA strategy for GMP capability.
• Lead QA activities to ensure compliance with GMP, company policies and client quality agreements.
• Review and approve analytical test records, raw data and certificates of analysis.
• Support investigations of deviations, OOS/OOT results and non‑conformances, driving root‑cause analysis and CAPA.
• Conduct internal audits and participate in external audits (MHRA, FDA, customer).
• Monitor data integrity and Good Documentation Practice standards.
• Develop and lead equipment qualification (IQ/OQ/PQ) for instruments such as HPLC, GC and balances.
• Manage Computer Systems Validation for LIMS, CDS, balances and environmental monitoring systems.
• Maintain the Quality Management System, including document control, change control and deviation handling.
• Contribute to continuous improvement of quality systems in the contract testing environment.

Required profile

• Experience working in a GMP‑regulated quality control laboratory.
• Ability to manage qualification and validation projects for analytical equipment and software.
• Familiarity with regulatory inspections (e.g., MHRA, FDA) and client‑specific quality agreements.
• Strong understanding of data integrity, Good Documentation Practice and CAPA processes.

Required skills

• GMP compliance
• HPLC, GC, analytical balances
• LIMS and other laboratory software
• Computer Systems Validation (CSV)
• Annex 11 and 21 CFR Part 11 requirements
• Equipment qualification (IQ/OQ/PQ)
• Data integrity and Good Documentation Practice

What we offer

• Starting salary £37,325 per year
• Permanent, full‑time contract
• Location in Dundee