Quality Release Associate

Location: Cirencester

Department: Quality Assurance

Are you a highly organised administrator with exceptional attention to detail? Do you thrive in a quality-focused environment where accuracy and compliance are critical? We are looking for a Quality Release Associate to join our Quality Assurance team and play a key role in ensuring our medical devices and instrument sets meet the highest standards before release.

The Role

As a Quality Release Associate, you will be responsible for reviewing completed batch records (DHRs) and releasing products for stock in accordance with documented work instructions and quality standards. You will work closely with multiple departments to ensure documentation is accurate, complete, and compliant with regulatory requirements.

This is an excellent opportunity for someone with strong administrative skills who enjoys working in a regulated environment and takes pride in delivering high-quality, accurate work.

We have roles on:

• Days: 8.30 - 1700 Mon-Fri
• Double days - Rotational: This role offers a 20% shift allowance
• Earlies: Mon-Thur 0515 - 1345 then Fri 0515 -1045
• Lates: Mon - Thur 1400 - 2230 then Fri 1100 - 1630

What you'll do:

• Review completed batch records (DHRs) and release products for stock in accordance with approved work instructions and checklists.
• Liaise with internal departments to resolve documentation queries and clarify any issues identified during DHR reviews.
• Publish regular updates regarding batch review and release activities.
• Perform transactional activities within relevant business systems, including Sage and IQM, supporting batch disposition and non-conformance reporting.
• Maintain quality records to ensure secure storage and efficient retrieval, including coordination of off-site records.
• Provide support to colleagues involved in batch release and associated documentation activities.
• Support Quality Assurance and cross-functional projects as required.
• Undertake general administrative duties to support departmental objectives.
• Provide documentation support during internal, customer, regulatory, and notified body audits.
• Ensure compliance with the Quality Management System (QMS), ISO 13485 requirements, Good Manufacturing Practice (GMP) standards, and FDA 21 CFR Part 820 regulations.
• Support Corrective and Preventive Action (CAPA) activities, ensuring timelines and process requirements are met in line with company procedures.