Summary
As Quality Manager and a senior Health Care Scientist, the post holder will work closely with the Clinical Immunology Services (CIS) Director and senior leadership to ensure the delivery of a patient centred, quality driven, efficient and cost-effective service. The CIS provides a comprehensive Clinical Immunology diagnostics service to the West Midlands, regional services in lymphoma/leukaemia diagnosis and national services for neuro-immunology and myeloma reporting. Being situated within the University of Birmingham, the CIS also provides central trials analysis for a number of national and local research studies and has a strong track record in immunodiagnostic development.
The post holder will provide guidance and advice in all issues relating to quality within the laboratory. They will report to laboratory management on the functioning and effectiveness of the quality management system via management review, senior staff, general laboratory and quality management group meetings or on an ad hoc basis. The post holder will ensure the implementation, development and maintenance of a quality management system in order to provide service improvement via; ensuring conformity with ISO 15189 accreditation standards, liaising with accreditation bodies and keeping up to date with changes in standards. The post holder will have excellent communication and management skills and lead liaison with other Quality Managers and end-users to establish satisfaction. The post holder will take a lead role in document control and audit within the laboratory and educate, promote and encourage all staff to participate in QM.
The post holder will have significant expertise in the laboratory medicine and as part of the laboratory’s senior management team, plan the activities and lead the development of the department. Operating with considerable autonomy, the post holder will supervise highly specialist clinical technical investigations including specialist assays, method and equipment evaluation/selection, research and development that incorporates medium to long term service development and enhancement.
The role is varied and includes the management of staff, provision and maintenance of services, and taking a lead role in the understanding and promotion of relevant health and safety requirements for medical laboratories. The role will include liaison with researchers to plan, cost, quality assure and deliver testing for translational research studies and clinical trials.
Main Duties
Senior leadership:
1. As part of the laboratory’s senior management team, plan the activities and lead the development of the department.
2. Contribute to general departmental management by performing, subject to consultation, such tasks as delegated by the laboratory manager.
3. Implement planned changes to the clinical technical service.
4. Plan and prioritise the workload of the laboratory.
5. Liaise with external agencies such as equipment manufacturers and engineers, suppliers of consumables.
6. Meet commercial representatives on behalf of the CIS.
7. Deputise for the laboratory manager at interdepartmental meetings, as required.
8. Other duties appropriate to the grade.
Clinical:
9. Prioritising, performing, interpreting, validating and authorizing specialist investigations according to standard operating procedures.
10. Providing technical clinical advice to clinicians and other practitioners. This advice will include information relating to, for example, test selection, sample quality, and sample timing.
11. Identify and communicate abnormal clinical results.
12. Continue to develop a wide range of scientific expertise and skill and apply this to clinical problems, including the development of new methods, or improving existing ones for routine use, clinical trial work or research.
13. Engage with end users to ensure their needs are met.
Technical:
14. Perform appropriate specialist laboratory procedures and tasks that are consistent with the job holder’s levels of specialist knowledge, skills and experience and take responsibility for the daily provision of the service.
15. Be up to date with contemporary methods including any analytical equipment used in the section and lead in the procurement of such equipment as is deemed necessary for the service.
16. Participate in equipment testing and adaptation as a function of service development.
17. Assess suitability and urgency of pathology samples. Assign relevant tests and investigations.
18. Ensure maintenance of equipment and stock control of consumables for the section.
19. Supervise and train technical, clinical, research and medical staff as required.
20. Monitor the performance of highly complex laboratory equipment and perform basic repairs in the event of malfunction.
Quality assurance:
21. As part of the laboratory’s senior management team take a lead role in supporting the quality manager to ensure departmental compliance with UKAS ISO15189.
22. Together with senior colleagues take a leading role in ensuring the department’s research activities are performed in accordance with GCLP and the requirements of MHRA.
23. Supervise and trend internal and external quality control and actively participate in the laboratory quality assurance and risk management programmes.
24. Report, investigate and document adverse events in accordance with departments risk management procedures.
25. Provide documentation as a function of the department’s accreditation with UKAS; for example, reviewing and updating standard operating procedures and documentation related to health and safety, competency, validation and verification.
26. Participate in and plan laboratory audit processes.
Required Knowledge, Skills, Qualifications, Experience
Knowledge:
27. In depth specialist knowledge of Immunology theory and practice particularly in relation clinical immunology diagnostics.
28. Detailed understanding of immune assays including trouble-shooting processes.
29. Detailed knowledge of quality management, especially in the context of the requirement of UKAS ISO15189.
30. Detailed understanding of HSST / Clinical Scientist professional standards, ethics and proficiencies.
31. Detailed understanding of health and safety matters related to medical laboratory science and familiarity with local, University and national legislation (. Health and Safety at work Act).
32. Detailed appreciation of the implications and requirements concerning the confidentiality of patient information (. General Data Protection Regulations, Caldicott principles, etc).
Skills:
33. Well-developed communication skills and the ability to communicate with staff and service users at all levels.
34. Ability to direct and prioritise division of work for other staff (technical and clerical).
35. Ability to motivate staff, promote good teamwork.
36. Ability to recognise and resolve complex problems with specialised reporting.
37. Responsibility for evaluation, interpretation and authorisation of patient results and training others in this process.
Qualifications:
38. Science degree acceptable to ACB or equivalent qualification.
39. State Registration with the Health and Care Professions Council or IBMS.
40. MSc or equivalent qualification/experience required.
41. Evidence of Continuing Professional Development in accordance with HCPC requirements.
Experience:
42. Significant experience working as a Health Care Scientist specialising in immunological diagnosis and monitoring desirable.
43. Experience in supervising small teams and taking responsibility for specific sections of the laboratory.
44. Actively participate in CPD to maintain in depth specialist understanding of relevant aspects of work.
45. Working with researchers to understand and deliver testing requirements for studies/clinical trials.
Planning and Organising
46. The post holder will be self-motivated and proactive with the ability to work independently and as a team leader.
47. The post holder will be expected to deputise for the laboratory manager when necessary.
48. Responsibility for prioritising their own work, and that of others, when necessary, subject to departmental objectives and requirements.
49. The ability to manage and prioritise a complex workload, often under pressure.
50. Ability to offer a supportive approach to others in achieving objectives.
51. Maintain an extremely flexible attitude to work to accommodate unplanned events.
Problem Solving and decision making
52. The role holder will decide on the short term and long term priorities in their section of the laboratory.
53. The role holder will decide which parts of the work are urgent and what must be reported urgently.
54. The role holder will decide which methods used within the laboratory are appropriate after evaluation and quality control has been carried out.
55. The role holder will decide if the results obtained are acceptable for release and if all quality control criteria have been met.
56. The volume of sample provided from very sick patients, particularly children, is often limited. The role holder will be expected to decide on the best use of the sample to give the Consultant Immunologist the maximum requested information to aid diagnosis as quickly as possible.
57. Participating in the selection/interviewing of staff with the BMS4 and making recommendations to HR.
58. Arranging staffing cover, both planned, and in the event of staff absences.
59. Recommending and/or implementing quality improvement measures.
60. Identifying and referring results on sample investigations to medical staff.
Internal and External relationships
61. Assist Laboratory Manager, Medical staff and other Scientists in the provision, maintenance and development of the service and standards of departmental quality and performance.
62. Demonstrate excellent communication skills and the ability to contribute positively to discussions with staff at all levels both within and without the department.
63. Ability to communicate results and deal with enquiries from laboratory and medical staff over sample requirements and results. This requires professionalism and attention to detail.
64. Assist Laboratory Manager, Medical staff and Scientists in the provision, maintenance and development of the service and standards of departmental quality and performance.
65. The role holder will liaise with clinicians in charge of individual patients to finalise arrangements for laboratory tests, provide detailed technical reports and information about which blood samples are appropriate for the tests to be carried out.
66. Develop and maintain good working relationships with all grades of staff from other hospitals and laboratories to whom a service is provided or where additional training is sourced.