At a Glance
- Tasks: Support Quality Management System compliance and contribute to quality processes like CAPAs and audits.
- Company: Join a team supporting GMP bio-pharmaceutical customers at Harbourgate, an ISO 9001 certified site.
- Benefits: Enjoy a collaborative work environment with opportunities for continuous improvement and professional growth.
- Other info: Role involves maintaining QA records and metrics to support decision-making.
- Why this job: Be part of a small team ensuring quality standards in laboratory operations and processes.
- Qualifications: Requires a Bachelor’s degree and 2-4 years of experience in Quality Assurance within regulated environments.
The predicted salary is between 30000 - 40000 £ per year.
The Quality Assurance Specialist works with a small team to provide Quality Management System support to global laboratory services teams (Validation Services and Process Development Services), and a local non‑manufacturing site (Harbourgate), 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.
Key Responsibilities
- 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.
Education
Bachelor’s degree (or equivalent) in an applicable scientific discipline.
Experience
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).
Skills
- 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.
Quality Assurance Specialist in Portsmouth employer: Danaher Corporation
Located at Harbourgate, this company supports global laboratory services teams in the bio-pharmaceutical sector. Employees benefit from a culture of compliance and continuous improvement, with a focus on ISO 9001 standards. The team values collaboration and effective communication across functions.
