- Closing date 25 Jun 2021
- Type Full-time
- Duration Permanent
Oxford Gene Technology (OGT) provides world class genetic research solutions to leading clinical and academic research institutions. We are a rapidly growing company with state-of-the-art facilities and over 100 employees based at our Cytocell® office in Cambridge and our head office in Oxford. With customers in over 60 countries worldwide and ambitious expansion plans, we have a strong reputation and increasing share in the large and growing genomic medicine market.
An opportunity has arisen within our Cambridge-based Regulatory, Medical and Quality Affairs Department which is responsible for regulatory compliance, generating technical evidence and maintaining the quality systems required for in vitro device manufacture and sales.
Reporting to the QC/QA Manager, your role will predominantly focus on Quality Assurance activities responsible for the management and maintenance of the Quality Management System, ensuring compliance with established processes and assisting in process improvement. You will also support the QC Team Leader with document auditing, batch release of final products and manufacturing/test equipment maintenance.
This is a key role in the roll-out of OGT’s new electronic Quality Management System (eQMS). Your role will be pivotal in the establishment of a number of core processes to support the new eQMS functionality and in the review and continual improvement of existing processes as they are transferred to the new system.
Quality Assurance duties will include:
- Establishment and maintenance of QMS processes and process improvement
- Coordination of customer complaints
- Coordination of change control requests and non-conformances raised
- Assisting in documentation control
- Internal auditing
Quality Control duties will include:
- Goods in testing of raw materials
- Manufacturing and test equipment maintenance and calibration
- Validation testing of new equipment
You will have:
- A BSc degree or equivalent in a science related subject, biology based or similar discipline
- Demonstrable experience working in a Quality Assurance / Quality Control role preferably within a highly regulated industry
- Experience of working in a production or laboratory environment
- Experience in the use of eQMS and internal auditing (desirable)
- Good attention to detail and accuracy
- Strong problem-solving skills
- Ability to work to deadlines and as part of a team in a sometimes highly pressurised environment
- Confidence to speak up and suggest process changes and improvements to deliver efficiency
In return you will receive:
- Competitive salary
- Pension Scheme (10% non-contributory)
- Private Health Insurance
- 21 days holiday rising with service
- High Street Discount Scheme
Application is via CV & a one-page covering letter outlining your suitability for the role, salary expectations and confirming you have the right to work in the UK.
Closing date for applications is 25 June 2021.
No agencies please