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Quality Assurance Specialist
2 months ago
We are seeking a highly skilled and experienced Quality Lead to join our team at the Cancer Molecular Diagnostics Laboratory (CMDL) at the University of Cambridge.
About the RoleThe successful candidate will provide leadership on all issues related to GCP and ISO laboratory quality management system, working closely with the Laboratory Director and Senior Scientific Staff. They will be responsible for maintaining and monitoring the regulatory compliance of the laboratory to the above standards and overseeing the associated quality management system.
Key Responsibilities- Maintain and monitor the regulatory compliance of the laboratory to GCP and ISO 15189:2022 standards
- Oversee the quality management system, including the controlled introduction of new procedures and the maintenance of an internal and external auditing programme
- Provide guidance and advice to staff and customers on all aspects of GCP/ISO compliance
- Assist in the production of remedial action plans as necessary
- Establish departmental quality meetings, including an Annual Quality Management Review
The post holder will be educated to degree level or equivalent in a life science related subject and have an in-depth knowledge of GCP, GCLP, HTA and ISO 15189:2022 regulatory requirements. They will have experience working in a quality assurance setting maintaining a quality management system, as well as experience working in a regulated GCP/ISO service laboratory with clinical trial samples.
What We OfferThe University of Cambridge offers a range of benefits, including training opportunities in quality assurance and the chance to work closely with Quality Leads and Clinical Trial Coordinators at the Cambridge Clinical Trials Unit.
How to ApplyApplications should be directed to Dr Shubha Anand, CMDL Director. The closing date for applications is 29th September 2024.
