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Senior Quality Assurance Officer

Job LocationNottingham
EducationNot Mentioned
Salary£33,000 - £35,000 per annum
IndustryNot Mentioned
Functional AreaNot Mentioned
Job TypePermanent, full-time

Job Description

Pure Healthcare Group are looking for a Senior Quality Assurance Officer to join one of our clients In Nottingham. This ISO 15189 accredited Pathology Service provide a complete histopathology and clinical diagnostic service producing cutting-edge diagnostic predictive and prognostic testing for cancer, and other diseases. The ISO 9001 accredited Genomics Services support academic and Biopharma research groups with state-of-the-art DNA sequencing and informatics analysis.You will be required to work with the Quality Assurance Manager and other Senior Managers, you will use your experience, skills and training to ensure new assays, services and processes are implemented in accordance with the relevant standards. Being an experienced Quality Professional, with a confident approach to collaboration, you will take a proactive role in identifying and solving compliance issues with staff at all levels of the business.In addition, this role will support the QA group by assisting monitoring and improvement of the Healthcare and Genomics services to ensure that the quality of work prioritises the safety of patients, meets the needs of our customers and complies with the requirements of relevant Quality Standards.Job Reference - PHG0097Pay: £33k - £35k depending on experience.Hours: 37.5 hours per week (9.00 - 17.30)Position: Senior Quality Assurance OfficerStart Date: ASAP - within 1 monthDuration: PermanentLocation: NottinghamKey Responsibilities

  • Support the QA Manager in the management of the QMS in accordance with the requirements of ISO 9001, ISO 15189, HTA and Good Clinical Practice (GCP)
  • Perform gap analyses against the relevant standard
  • Identify areas of potential problems and improvements
  • Conduct start-up audits for new services
  • Host external audits
  • Review and assist completion of the following documents for standard compliance:
  • Change controls
  • Risk assessments
  • Validations
  • Be responsible for tracking completion of project documentation
  • Perform effectiveness checks on projects post-implementation
  • Prepare documents for regulatory submission
  • Performing raw data and end-of-study audits for GCP compliance
  • Provide support to all members of the QA group where required
  • Availability to travel (as required)
  • To be considered for the role you must have the following:Essential:
  • BSc (or equivalent) in a science-based subject or relevant experience within a regulated industry
  • Greater than four years’ experience working within an accredited healthcare QMS (e.g. ISO 15189 or ISO 17025)
  • Experience reviewing change controls, validations, risk assessments and non-conformities
  • Have experience performing internal audits, supported by appropriate training
  • Strong administrative and IT skills
  • Ability to work as part of a team to complete tasks and implement improvements
  • Desirable:
  • Experience implementing new services
  • Experience of participation in regulatory audits
  • Familiarity with Q-Pulse or similar Electronic Quality Management System
  • Full driving license
  • Benefits include:
  • 25 days holiday plus bank holidays
  • Additional day off on your birthday
  • Opportunity to buy/sell up to 5 days holiday a year
  • Flexible working
  • Income protection
  • Death in Service benefit
  • Health cash plan
  • Discretionary bonus depending on company performance
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