Quality Assurance Associate

  • Closing date 8 Nov 2020
  • 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 to join 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 as a QA Associate.

Reporting to the QC Team Leader, you will assist with the management and maintenance of the eQMS system, validate, calibrate and maintain equipment, assist with document auditing and batch release of final products and with general QA activities

Your duties will include:

  • Management and maintenance of eQMS system including document control, non-conformance/CAPA, internal and external audit actions.
  • Ensuring all equipment used in the development and manufacture of Cytocell products is calibrated and in good working order.
  • Promptly dealing with any equipment failures and if necessary, removing from use.
  • Maintaining equipment history and ensuring accurate maintenance records are kept.
  • Liaising with suppliers regarding service and calibration requirements.
  • Validation testing of new equipment to ensure it is fit for purpose.
  • Timely completion of all paperwork.
  • Document auditing and batch release of final products.
  • Reporting non-conformances to the QC Team Leader.

You will have:

  • Degree in a science related subject, biology based or similar discipline or equivalent experience
  • Experience of Quality system such as ISO 9001 or ISO 13485 (desirable)
  • Experience within a production environment (Quality Assurance or Regulatory desirable)
  • An organised approach to work
  • A good eye for detail
  • The ability to follow detailed processes

In addition, you will work under the relatively close supervision of your Team Leader with work undertaken on the basis of rigid testing instructions and being checked on a daily basis, so you must be comfortable with extremely limited autonomy for making decisions.

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 to [email protected]

Closing date for applications is 8th November 2020.

No agencies please

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