Job Summary
We are currently seeking a Quality Officer to join our QA ATMP within the Quality Directorate. The role of the Quality Officer is to provide independent advice, guidance and support in the use of our quality systems. The Quality Officer will also assist in monitoring our quality system on a day-to-day basis, ensuring that all licensing and accreditation activities are undertaken as they should be. The Quality Officer will support the delivery of essential training to staff and monitor quality system performance across the ATMP departments. A key activity will be the facilitation and management of the Incident Management system, in collaboration with internal and external business users.
This post reports to the Quality Assurance Manager – ATMPs and whilst will be based at Birmingham they will support all of the ATMP sites (Filton, Liverpool, Barnsley and Birmingham) The role requires some on site activities but also has the flexibility for working remotely.
Main duties of the job
About the Role
1. You will assist the Quality Assurance Manager in the smooth running of the Quality Assurance Department, including team briefings, training, planning and prioritising workload of the team
2. You will be responsible for assisting in the licensing and accreditation activities by liaison with all departments, providing advice and training in the NHSBT quality management systems
3. You will assist in the management of an incident reporting system, and a complaint handling system, by engaging with both internal and external stakeholders
4. You will support the Assistant QA Managers in product batch review and release.
5. You may be responsible for the management of small-scale change controls and quality incidents.
6. You will be responsible for monitoring national inboxes and escalating problems as required.
7. To support activities some travel throughout the UK and spending some time away from base, which may involve working irregular hours and occasional overnight stays may be required, this will be with prior notice.
About You
Experience and Knowledge
8. Experience in a regulated (Good Manufacturing Practice, NHSBT or equivalent) environment
9. Knowledge and understanding of human organ, tissue and cells, blood and medicines legislation across the UK
10. Knowledge of diagnostic testing, donation of blood and tissues, principles of the collection and storage of tissues, principles of organ donation and transplantation
11. Knowledge of blood collection, testing, manufacturing and issuing processes
12. Experience of working with information technology using Microsoft Office packages (Word, Excel and PowerPoint), or equivalent systems
13. Experience of using IT systems to produce reports and correspondence which are timely, professional and accurate
Qualifications and Training
14. Educated to degree level in a related subject e.g. Biomedical Science, Pharmaceutical or equivalent professional qualification or experience.
15. Evidence of continuous professional development.