Quality Assurance Associate

Job Description

Quality Assurance AssociateOxford 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 activitiesQuality Assurance Associate Responsibilities:- 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.Quality Assurance Associate Requirements:- 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.Closing date for applications: 8 November 2020.Location: CambridgeJob type: Full time, PermanentSalary: up to £25,000 paBenefits: Generous Pension Scheme (10% non-contributory). Private Health Insurance. 24 days holiday a year rising with service. Attractive High Street Discount Scheme.You may have experience of the following: Regulatory Affairs, Quality Control, QA Assistant, Quality Control Assistant, Quality Assistant, Quality Assurance Assistant, Pharmaceutical, Manufacturing, Production, etc.Ref: 94756No agencies please