QA/RA Assistant/Manager

QA/RA Assistant/Manager– £35,000- £45,000– Central Tech, L3 5LJ

The Role

Are you highly organised with a sharp eye for detail in regulated environments? Ready to build your career in quality and regulatory affairs while helping shape standards in a growing laboratory setting?

This is an exciting opportunity for a QA/RA Assistant/Manager to join Guilford Street Laboratories and play an important role in maintaining and improving the Integrated Management System (IMS).

As a QA/RA Assistant/Manager, you will support quality, regulatory and information security processes while helping ensure compliance across laboratory operations. This role offers the chance to work closely with technical teams, strengthen your expertise and develop your career within diagnostics, healthcare and laboratory quality systems.

If you are ready to take the next step in your career and join a forward-thinking laboratory team, apply today and help shape quality excellence at Guilford Street Laboratories.

Key Responsibilities:

• Support the maintenance and continuous improvement of the IMS
• Assist with compliance across ISO 15189, ISO 13485, ISO 27001, UKCA, CE, and relevant FDA/IVDR requirements
• Manage controlled documentation, including SOPs, policies, and laboratory procedures
• Support internal and external audits, including CAPA tracking
• Work alongside laboratory teams to maintain quality standards across testing and data integrity
• Assist with supplier, reagent, and service provider approvals
• Support risk management, nonconformance, and change control processes
• Maintain training and competency records
• Provide administrative support to the Quality and Regulatory department

The Company

Guilford Street Laboratories is committed to reshaping the future of diagnostics. We apply cutting-edge machine learning to unlock better ways to detect, stratify, and monitor disease. Our values—innovation, accuracy, collaboration, empowerment, and service—guide everything we do. At Guilford Street Laboratories, your work will directly support healthcare professionals in delivering earlier and more accurate diagnoses for patients worldwide.

Benefits:

• Salary of £35,000–£45,000
• Full-time position, 35 hours per week
• Career development within a regulated scientific environment
• Exposure to leading laboratory and regulatory standards
• Supportive and collaborative team culture
• Valuable hands-on experience across quality and regulatory systems

The Person

We are looking for a QA/RA Assistant/Manager who has:

• A degree in Biomedical Sciences, Life Sciences, Laboratory Sciences, Quality Management, Regulatory Affairs, or similar
• Previous experience within a laboratory, IVD, diagnostics, or regulated healthcare setting
• Strong knowledge of laboratory quality systems
• Excellent organisational and communication skills
• Confidence working with controlled documentation
• A real interest in diagnostics, laboratory quality, and regulatory compliance