Quality Assurance Specialist

1 month ago


Cambridge, Cambridgeshire, United Kingdom University of Cambridge Full time
Job Summary

We are seeking a highly skilled Quality Assurance Specialist to join our team at the University of Cambridge. The successful candidate will provide leadership on all issues related to GCP and ISO laboratory quality management system.

Key Responsibilities
  • Provide guidance and advice to staff and customers on all aspects of GCP/ISO compliance
  • Oversee the controlled introduction of new procedures and maintain an internal and external auditing programme to identify areas of regulatory risk
  • Manage and be administrator for the Quality Management Information System (Ideagen, previously Q-Pulse)
  • Establish departmental quality meetings including an Annual Quality Management Review
Requirements

The ideal candidate will have an in-depth knowledge of GCP, GCLP, HTA and ISO 15189:2022 regulatory requirements. They will also 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 Offer

The 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.

The successful candidate will also have opportunities to complete an online Health and Safety course as appropriate for the role.

About Us

The University of Cambridge is a world-leading institution with a strong commitment to quality and excellence. We are proud to be a part of the Cancer Research UK Cambridge Centre, funded by NIHR-BRC and CRUK CC Integrated cancer medicine theme.



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