Specialist Biomedical Scientist in the Quality Assurance Laboratory

This is a leadership role; the post holder will facilitate the specialist technical and associated Quality Control (QC) testing programmes of the Laboratory. This will include utilising varied technologies such as those associated to Haematology, Haemostasis and Flow cytometry, to analyse samples and establish process capability metric data. Environmental sampling to monitor the cleanliness of critical areas and equipment and calibration and validation of cold chain monitoring systems.
The successful applicant will work to a level to ensure all processes meet the requirements of the UK guidelines for Blood Transfusion and the EU Directive as inspected by the Medicines and Healthcare products Regulatory Agency (MHRA).
There will be a potential requirement to work variable shift patterns according to the exigencies of the service. This will include seven day working, Bank Holidays and a requirement to participate in a 24/7 on-call rota. Applicants must be within a 30-minute journey time of the Talbot Green Headquarters., Specialist Biomedical Scientist in the Quality Assurance Laboratory
The Specialist BMS in the QA laboratory, is a leadership role and with the appropriate training, will be expected to perform the specialist technical and associated procedures unsupervised. The Specialist BMS will be required to assist in the developmental work of the department. With experience the Specialist, BMS may on occasions be required to lead and be accountable of any section of the QA Laboratory in the absence of the Head or Section Leader of the department. The Specialist BMS may, provided they have been authorised by their Departmental Head, both supervise and train other Biomedical Scientists, Trainee Biomedical Scientists and Medical Laboratory Assistants. Biomedical Scientists (BMS) will be registered under the provisions of the Health and Care Professions Council. The post holder will also be required to work flexibly and the 'On-call' rota for the Welsh Blood Service., Planning and Design
¨ Responsible for planning & prioritising own workload.
Improvement and Monitoring
¨ The post holder will be expected to trouble-shoot and diagnose faults on the complex equipment
¨ The post holder, will be responsible for ensuring that all equipment and processes are maintained in a validated state, reporting deficiencies to their manager.
¨ The post holder will be responsible for the calibration, validation of critical test kits and equipment
¨ The post holder may be requested to prepare Operating Procedures
¨ The post holder will be expected to follow all policies/procedures and SOPs identified as a requirement of their job role. This will involve reading and understanding relevant polices and being trained to SOPs.
¨ The post holder will be expected to support and participate in the production of peer reviewed publications, including posters, abstracts and presentations.
Communications
¨ The post holder will be required to demonstrate effective communication and team working skills with colleagues in their own team/department, staff in other departments of the WBS and external customers. Examples of this will include the taking and passing on of accurate messages to person(s) who need to know, providing information when requested, participating fully within the team.
¨ The post holder will be required to communicate both verbally and in written format with internal colleagues and external customer hospitals as directed by the Head of Quality Assurance Laboratory to ensure the service requirements are met.
Clinical and Scientific
¨ The post holder will be required to perform specialist technical and scientific procedures in the four sections of the Quality Assurance Laboratory.
¨ The post holder will be required to possess a BSc Hons in Biomedical Sciences or other honours degree approved by the Institute of Biomedical Science (IBMS) for registration with the Health and Care Professions Council (HCPC).
¨ The post holder must be a registered BMS with the HCPC.
¨ If registration qualification has been achieved through the IBMS Registration Portfolio the post holder will be required to complete or have attained the IBMS specialist portfolio in Transfusion Science and GMP as a pre-requisite for a specialist BMS post. This typically requires at least 2 years post graduate study to diploma level.
¨ The post holder will be required to participate in the Continuing Professional Development (CPD)
¨ The post holder is required to have a thorough working knowledge of the requirements of external regulatory requirements to which the WBS must comply. These will include MHRA/BSQR, UKAS.
¨ The post holder will be required to have a thorough understanding of the principles of Good Manufacturing Practice (GMP) and its role in WBS quality systems.
¨ The post holder will be required to demonstrate an awareness of all relevant guidelines to which the WBS must adhere. These will include UK Guidelines for Transfusion Services (Red Book), Council of Europe Guidelines, and relevant BSH Guidelines.
¨ The post holder will be responsible for the preparation of samples and testing on specialised automated equipment.
¨ Interpret diagnostic test results and refer any out of control or abnormal results to the senior staff within Quality Assurance Laboratory for subsequent referral onto the medical staff of FBC results that may indicate the need for a clinical referral.
¨ Ensures that all specialist equipment is maintained in a calibrated state by the use of appropriate control and reference samples, thus ensuring that any patient results or quality monitoring samples can be reliably reported.
Finance and Budget
¨ Responsible for the safe use of expensive and highly complex equipment,
¨ Responsible for maintaining stocks of disposable and recyclable items and ordering from stores to agreed financial limits.
¨ Maintenance of adequate stock levels of both in-house prepared and commercial reagents.
¨ Assist with evaluation and validation of equipment and processes being introduced at the Welsh Blood Service (WBS).
¨ Assist Section Leaders in the maintenance of chemical and reagent stock and ensure safe disposal of samples and waste. Assist in the management of COSHH.
Management, Leadership and/or Training
¨ The post holder will be required to prioritise their own work and the work of their colleagues once they have been deemed competent to do so. Examples of this will include the prioritisation of routine work against research activities, or the prioritisation of calibration activities that are scheduled against validation activities following the failure of GMP critical equipment.
¨ The post holder will be expected on occasions to work and report autonomously within defined laboratory procedures e.g. CD34+ and on-call
Digital and Information
¨ Assist the HOD or section leader in the collection of quality control data for Statistical Process Control/Monitoring and enter test results onto the appropriate computer software packages to maintain and improve the Quality Systems. Identify any problems and initiate appropriate agreed corrective action.
¨ The postholder will be required to create statistical reports
¨ Perform regular data back-up

The ability to speak Welsh is desirable for this post; English and/or Welsh speakers are equally welcome to apply., Essential
· BSc Hons in Biomedical Sciences (accredited by IBMS) for HCPC registration
· Registered with HCPC
· IBMS Specialist Portfolio in Transfusion Science (or equivalent qualification where appropriate or evidence of working towards completion)
· Participating in a CPD scheme
· Knowledge of Regulatory requirements i.e. MHRA, CPA and ISO
· Knowledge of UK Guidelines for Transfusion Services (Red Book) and relevant BSQR, BSH & Council of Europe Guidelines
Essential
· Previous employment as a registered BMS whilst completing Specialist Portfolio
· Previous experience of quality control, sampling analysing and reporting data metrics
Desirable
· Previous experience of QA
· Previous experience of root cause analysis and investigation techniques
· Previous Experience of change management
Skills and Attributes
Other
· Ability to communicate effectively both orally and in written format
· Ability to work effectively as part of a team
· Generic Laboratory skills e.g. pipetting, microscopy etc.
· Planning & Organising skills
· Good interpersonal skills
· Practical approach to problem solving
· Presentation skills
· Data graphics and Analytics
Desirable (but not essential): Welsh Speaker (Level 1) or willingness to work towards
An interest in the field of Blood transfusion & GMP, Enthusiasm for the career applied for
It is essential that your application demonstrates how you meet the job description / person specification for this post.
To work in the UK, all candidates who are not UK or Republic of Ireland (RoI) nationals require sponsorship to obtain either a Health and Care visa or Skilled Worker visa, unless you have permission to work via another route. Non UK / RoI candidates wishing to apply should self-assess the likelihood of obtaining a Certificate of Sponsorship by visiting Work in the UK. If you are eligible for the Health and Care visa, application costs are lower and you do not need to pay the annual Immigration Health Surcharge.

Velindre University NHS Trust will be recognised locally, nationally and internationally as a renowned organisation of excellence for patient and donor care, education and research.
Our values;
+ Caring
+ Respectful
+ Accountable
and who will complement our current experienced and specialist employees, who are passionate about working in an organisation with the ambition to provide world class services & care to our donors.
The WBS is immensely proud of the vital role it plays in modern healthcare, striving to save and transform lives through the generosity of donors. WBS is an amazing place to work and develop your career. Our caring and motivated staff are designing, developing and delivering improvements through the Supply Chain 2020 (BSC2020) initiative, which will enable the WBS to strive towards its vision of working with our staff & the people of Wales to deliver an easy to use, safe and sustainable service for blood and stem cell donation.
Applications may be submitted in Welsh. Applications submitted in Welsh will not be treated less favourably than an application submitted in English.
Please check your email account regularly. Successful applicants will receive all recruitment related correspondence via the email account registered on the application form.
The salary scale above has been agreed as part of the NHS Agenda for Change pay award for 2024/2025 and will be implemented in November 2024 backdated to 1st April 2024 where applicable., Here at Velindre University NHS Trust we are extremely proud of the specialist services we provide across the whole of Wales in our cutting-edge Velindre Cancer Centre and our award-winning Welsh Blood Service, as well as the expertise of our corporate functions that bring the two divisions together. We are also fortunate to host the NHS Wales Shared Services Partnership and Health Technology Wales and have developed strong partnership working with these expert services.
Formed in 1999, the Trust has a dedicated workforce that continuously strives to apply the key principles of value based healthcare through a wide array of roles. We play a vital role in the communities we support and have ambitious plans for the future to continue to improve the services we deliver. We strive to maintain our core values in everything we do by being; accountable, bold, caring and dynamic, and ensuring the best possible care for our patients and donors.
If you want to work for an organisation that prides itself on making a real difference and offers exciting career opportunities then Velindre University NHS Trust is the place for you.