Quality Assurance Specialist

Blackfield Associates is partnered with an innovative biotechnology company based in Cambridge in the search for a Quality Assurance Specialist.

As the Quality Assurance Specialist, you will play a vital role in operating the Quality Management System in compliance with current Good Manufacturing Practices. This position is both administrative and operational, engaging in key QMS activities while supporting colleagues across the business to ensure procedural compliance.

Key responsibilities within the position will be (not limited to):

• Contribute to the implementation and management of a cGMP-compliant Quality Management System, including internal auditing, stability programs, process validation, tech transfer, change control, deviations, investigations, corrective actions, and risk management.

• Support audits conducted by customers and regulatory bodies, ensuring the company maintains high standards of compliance.

• Deliver training sessions, both group and individual, on QMS and cGMP topics to ensure comprehensive understanding across the business.

• Maintain accurate QMS documentation, keeping detailed records and ensuring adherence to company policies in line with cGMP regulations.

• Promote the importance of quality and compliance, building strong working relationships with the Production and Quality Control teams.

The ideal candidate for this role will hold a degree with relevant industry experience and demonstrate a strong understanding of cGMP. You should possess a keen attention to detail, be capable of working independently or as part of a team, and have a methodical approach to prioritizing tasks. The right to work in the UK is essential for this role.

If you are interested in this opportunity, please send your up-to-date CV to Oliver@BlackfieldAssociates.com or call Oliver on 02392 314 792.