Job Summary
As an experienced Biomedical Scientist with an eye for detail, you will assist in ensuring NHSBT Reagents continues to excel at meeting all regulatory requirements. You will be part of the team supplying CE marked products to hospitals and blood transfusion services in the UK. You will be responsible for the product release and management of medical device files including the collation and interpretation of information to ensure ongoing compliance. As an experienced Biomedical Scientist this will also include working alongside other Biomedical Scientists in generating results in the laboratory.
You will have an opportunity to develop skills in specialised transfusion techniques, audit and compliance knowledge to assist in ensuring that information is available to customers and regulators.
You will join an organisation with a commitment to our core purpose of improving and saving patient ‘s lives and in staff development. You will contribute to developing and providing a high-quality service, that meets the varied needs of customers and ensures the safety and wellbeing of patients.
Main duties of the job
You will be working as part of the Reagents senior management team. Your responsibilities will include :-
1. Ensuring that documents and practices in NHSBT Reagents comply with regulatory requirements including ISO, Good Manufacturing Practice, In Vitro Diagnostics Directive, and NHSBT’s Quality Management system.
2. Writing and maintaining the product medical device files to meet these requirements.
3. Approving release of NHSBT Reagents’ products, following scrutiny of Batch Manufacturing Records, and sign lot specific certificates of conformance.
4. Maintaining records of batch manufacture and release.
5. Monitoring trends in Quality Indicators.
6. Working with Quality Project Specialist(s) leading on IVDD compliance to achieve these objectives.
7. Planning and conducting quality audits of NHSBT Reagents and Reagents related processes.
You may be required to travel and spend time away from base, which will involve working irregular hours and overnight stays when required, with prior notice
About You
Experience and Knowledge –
8. Well developed specialist knowledge in reagents production and regulatory compliance
9. Experience of working in a highly regulated environment, relevant to diagnostic services including in depth knowledge of standards and guidelines affecting laboratory practice and reagents production
10. Skilled in audit, validation of equipment, processes, research and development activity
11. Experience of working with Information Technology using Microsoft Office packages (Word, Excel and PowerPoint) and databases
12. In depth understanding of NHSBT and wider healthcare community
Qualifications and Training –
13. HCPC professional registration required (which must be maintained in the role)
14. First Level Sciences degree
15. Willingness to work towards and complete MSc or FIMBS within 3 years of registering on the course
16. Post HCPC registration qualification
17. Demonstrate commitment to and evidence of own Continued Professional Development (CPD).