We are seeking a proactive and organised Quality Assurance Officer to support and maintain a company’s Quality Management System (QMS). The organisation is a growing biotechnology company focused on high-quality, science-driven product development, with a strong emphasis on quality and continuous improvement. This role is central to ensuring compliance, audit readiness, and effective day-to-day QMS operations as the organisation evolves its systems to support growth and an expanding product portfolio.

The successful candidate will manage ISO 9001 activities, including maintaining QMS documentation, overseeing training records, preparing quality documentation for products and customers, and conducting internal audits while supporting external audits. They will act as the first point of contact for quality queries, enabling the Quality Lead to focus on strategic GMP-aligned system development.

This is a hands-on, site-based role requiring strong attention to detail, excellent organisational and communication skills, and a collaborative, proactive approach.

Requirements

Essential:

• Experience with QMS (e.g. ISO 9001 or ISO 13485)
• Proficiency in quality tools and systems
• CAPA experience and root cause analysis
• Strong attention to detail and teamwork
• Knowledge of laboratory or SOP-driven environments

Desirable:

• Understanding of regulatory standards in biotech/life sciences
• Supplier quality and audit experience
• Experience delivering quality training programmes