In this role you will work closely with our Quality Manager and will be responsible for managing and maintaining the Quality Management System (QMS) to ensure compliance with applicable standard (ISO 9001).
Cellular Origins are currently in the process of obtaining ISO 9001 this role will be to support the Quality Manager and the wider business with completing necessary steps to achieve this. Part of the role will be to support continuous improvement initiatives ensure document and record control management and get involved with internal and external audits.
You will administer and maintain the electronic Quality Management System (eQMS) you will manage the document control processes including review revision and archiving of quality documents where and when necessary (SOPs WI forms).
- Develop and provide training to QMS..
- Oversee that training records are maintained.
- Ensure system compliance with quality standards and applicable regulations.
- Support audit readiness by maintaining accurate and uptodate records.
- Assist with internal and regulatory audits.
- Track and report on quality metrics (e.g. CAPAs NCRs training compliance).
- Coordinate and monitor corrective and preventive action (CAPA) processes.
- Collaborate with crossfunctional teams to drive continuous improvement.
- Support risk management activities and change control processes.
Qualifications :
Essential:
- Experience in a regulated industry (e.g. medical devices pharmaceuticals healthcare finance engineering: environment aerospace or automotive for example).
- Experience working with Quality or Business Management System environment and ISO standards.
- Proficient in eQMS platforms
- Experience of the entire audit process. Strong organisational and documentation skills.
- Strong attention to detail with excellent problemsolving abilities.
- Proficient in Microsoft Office Suite.
- Ability to manage multiple tasks and prioritise effectively.
- This role will be a full time onsite position at our campus in Melbourn.
Desirable:
- Experience working with collaboration tools (e.g. JIRA Confluence).
- Knowledge of ISO 9001 ISO 13485
- Internal auditor certification.
- Knowledge in Cognidox/Sharepoint)
Additional Information :
Cellular Origins is part of TTP Group an employeeowned business. It is based on the TTP Campus within purposebuilt sustainable offices labs and green surroundings 10 miles south of Cambridge. TTP Group takes a longterm approach to investment and has been at the forefront of bioprocess automation for over 20 years. Our working culture encourages entrepreneurship shared ideas and collaboration while providing you the freedom to do your best work.
Our employee benefits include:
- Annual profitrelated bonus
- 25 days holiday
- Employer pension contribution of 10% of salary
- Free lunch and allday refreshments
- Private medical insurance for employees and dependants
- Enhanced family friendly leave
- Life insurance worth 6x salary
- Electric car leasing scheme
- Cycle to work scheme
- Season ticket loan
- An activities and community fund that supports healthy activities that bring colleagues together; whether its lunchtime squash or football Zumba or our own rock band. Colleagues initiate new clubs and outings whenever they feel theres something missing!
- Local sports facilities and theatre discounts and memberships.
Remote Work :
No
Employment Type :
Fulltime