Quality Assurance Specialist

Role Summary

The Quality Assurance Specialist works with a small team to provide Quality Management System (QMS) support to global laboratory services teams (Validation Services and Process Development Services), and a local non‑manufacturing site (Harbour gate), both operating within ISO 9001 certified environments and supporting GMP bio-pharmaceutical customers.

The role ensures QMS requirements are consistently applied, maintained and evidenced across laboratory operations and site processes in line with customer, certification and internal quality expectations

• Support day‑to‑day maintenance and effective use of the site Quality Management System in compliance with ISO 9001 and applicable GMP expectations.
• Contribute to quality processes such as deviations, CAPAs, document control, change control, risk management, training compliance, complaints management, customer questionnaires and audits, as applicable.
• Support preparation for, participation in, and follow‑up of internal, customer and certification audits.
• Partner with laboratory operations and support functions to ensure quality requirements are understood and embedded into routine activities.
• Promote a culture of compliance, data integrity and continuous improvement using structured quality tools and standard procedures.
• Maintain accurate, timely QA records and metrics to support decision‑making and QMS effectiveness.

• Bachelor’s degree (or equivalent) in an applicable scientific discipline.

• Typically 2–4 years’ experience in a Quality Assurance or Quality Systems role, within a regulated or ISO‑certified environment (e.g. life sciences, laboratories, pharma services).

• Working knowledge of ISO 9001 and core Quality Management System principles, with the ability to apply procedures across laboratory operations and site processes.
• Strong analytical and problem‑solving skills, able to investigate issues, assess risk and support effective corrective actions.
• Clear written and verbal communication skills, with the ability to work collaboratively across functions and with external customers or auditors.