Senior Biomedical Scientist – Quality Lead

Job summary

As a category 1 responder UKHSA has a critical responsibility to scale laboratory diagnostic capacity within the first 6 weeks of an emerging threat with epidemic or pandemic potential. One way in which this will be delivered is through a new standby semi-automated and high throughput PCR testing facility at our Porton Down scientific campus. We are therefore looking for an HCPC registered Senior Biomedical Scientist to lead delivery of the facility’s quality management system.

Successful applicants will join a new team, Amplify, within the Diagnostic and Pathogen Characterisation Division and work alongside colleagues in the Rare and Imported Pathogen Laboratory (RIPL) and Diagnostic Development and Implementation team. You will be responsible for overseeing the development and implementation of the facility’s quality management system, under the umbrella of RIPL, the co-located and ISO 15189 accredited clinical laboratory for rare, emerging, imported and high consequence infectious diseases.

The Post holder will be expected to be flexible to the demands of the project area, have excellent communication skills and use their technical experience to ensure the service is delivered on time and remains ready to respond. This will include changing patterns of work to include out of hours shifts when incident or outbreak response mode is activated and supporting the delivery of research testing and training activities in support of wider organisational priorities.

We pride ourselves as being an employer of choice, where Everyone Matters promoting equality of opportunity to actively encourage applications from everyone, including groups currently underrepresented in our workforce.

UKHSA ethos is to be an inclusive organisation for all our staff and stakeholders. To create, nurture and sustain an inclusive culture, where differences drive innovative solutions to meet the needs of our workforce and wider communities. We do this through celebrating and protecting differences by removing barriers and promoting equity and equality of opportunity for all.

Please visit our careers site for more information https://gov.uk/ukhsa/careers

Job description

• Implement quality improvements as appropriate, involving the development of new protocols and procedures.
• Maintain close links between quality and governance arrangements, including leading adverse incident investigation and management.
• Support laboratory staff to perform quality activities and monitor their effectiveness; review current Quality and Governance reports.
• Champion Change Control within the Department.
• Provide expertise and practical support for preparation for, and organisation of, inspections by third party assessors, such as UKAS and certification bodies, commercial organisations, or research councils and to progress issues arising from these assessments and inspections.
• Report directly to the facility manager and RIPL Quality Manager on the performance of the quality management system and identify any need for improvement.
• Ensure participation in suitable EQA surveys and monitor results, feeding back management any deficiencies and working with Technical Specialists and Bench Leads to address any issues.
• Ensure the promotion of awareness of service users’ needs and requirements throughout the laboratory organisation.
• To provide Quality feedback on laboratory performance with regular communications via emails, reports and presentations.
• Take a leading role in risk management for the department, managing a local risk register and escalating risks that cannot be controlled via appropriate channels.
• Participate in routine and out of hour testing rotas to ensure provision of sufficient testing capacity in line with business needs.
• Deliver training to internal and external scientists in support of wider pandemic preparedness activities, with a focus on how to implement effective QMS for high throughput testing facilities.
• Line manage junior team members, and ensure effective prioritisation, co-ordination and supervision of work.
• Deputise as appropriate for senior staff and act as head BMS in the absence of the facility manager.
• Supply data to agreed timescales and as required by project contracts and service level agreements.
• Undertake general laboratory duties including disposal of waste, equipment maintenance, stock control and ensuring a safe working environment.
• Maintain HCPC registration as a condition of employment.
• Fulfil all training requirements as required for the post, including subsequent maintenance of required competencies.
• Maintain high professional standards by continual professional development keeping up to date with advances in medical microbiology
• Ensure all work in undertaken in accordance with the UKHSA’s Code of Safety Practice and to work within ISO15189 quality standards.
• Ensure health, safety and welfare are afforded priority and demonstrate a commitment to health, safety and welfare of self, staff and visitors and comply with relevant UKHSA health and safety policies at all times.
• Notify accidents, near misses, dangerous situations and shortcomings in health and safety via the appropriate management structure.
• Escalate risks that cannot be controlled to the Facility Manager.
• Fully engage with the performance process, including objective setting and preparing for performance conversations, as described on the UKHSA intranet.
• Fulfil the requirements of UKHSA Values and Behaviours and the Civil Service Code.
• Comply with all UKHSA policy and procedures.
• Perform any other duties required by the line manager commensurate with grade.

Main Duties

• Implement the facility’s quality management system (QMS), ensuring compatibility and compliance with the RIPL QMS to enable ISO 15189 accreditation under a single schedule of accreditation.
• Support and train laboratory staff to perform quality activities and monitor their effectiveness.
• Deputise as appropriate for senior staff and act as head BMS in the absence of the facility manager.
• Deliver training to internal and external scientists in support of wider pandemic preparedness activities, with a focus on how to implement effective QMS for high throughput testing facilities.
• Participate in routine and out of hour testing rotas to ensure provision of sufficient testing capacity in line with business needs.

Please note this list is not exhaustive.

Person specification

Essential role criteria:
• BSc Hons in a biological science
• MSc or higher qualification in an appropriate medical/microbiology/biological science or relevant experience as a specialist biomedical scientist
• Registration with the Health and Care Professions Council (HCPC) as a Biomedical Scientist
• Experience of implementing and overseeing Quality Management Systems in an ISO 15189 accredited diagnostic molecular laboratory
• Experience of managing change and instigating system improvements from a quality management perspective
• Substantive experience in a diagnostic or reference virology laboratory, including knowledge and experience of automated high throughput real-time PCR
• Ability to analyse and interpret information including performance indicators, pre-empt and evaluate issues, and recommend an appropriate course of action to address the issues or areas of risk

Desirable role criteria:
• Technical knowledge and experience in developing and implementing quality systems for automated, high throughput testing workflows, ensuring compliance with ISO 15189 and UKHSA standards and policies.

Benefits

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