Job responsibilities
- Work independently to fulfil the laboratory quality related responsibilities and functions including suggesting and driving quality improvements and management of control of change procedures.
- Project manage laboratory-based accreditation in liaison with accreditation bodies and undertake a lead role in the performance of gap analyses against appropriate standards.
- Manage and organise the preparation for inspections by third party assessors, including UKAS, commercial organisations or research councils with whom collaborative and contract work is being undertaken. Progress quality issues arising from these inspections.
- Implement and manage the laboratory audit system. This includes organisation of internal and external audit programmes, managing the corrective actions arising, planning and carrying out internal quality audits against ISO15189, ISO17025, ISO9001, and other standards in accordance with approved audit plans and report the findings.
- Organise and lead the Annual Management Review. Analyse, collate and present data, including reports for discussion and assist development and implementation of quality objectives.
- Produce regular quality reports to identify early warning signs of the emergence of service delivery or quality issues, or to provide the evidence to make considered informed decisions.
- Develop a strategy for, and implement the measuring and monitoring of, key process and performance indicators within the laboratory.
- Work collaboratively with the Technical Manager and other staff to ensure awareness of laboratory quality activities and issues in the laboratory and supervise laboratory staff performing quality assurance activities and monitor their effectiveness.
- Write, edit or commission QMS-related documentation.
- Contribute to the quality aspect of validation documentation to support current testing strategies and for the development of new assays.
- Assist in the identification, evaluation and adaptation of new technologies and diagnostic tests to enhance the laboratories capabilities and to ensure the project area works to a high scientific standard.
- Supply data to agreed timescales required by Pathogen Genomics service level agreement.
- Complete training requirements as required for the post.
- Ensure all work is undertaken in accordance with the UKHSAs Code of Safety Practice and to work within a Quality system acceptable with the site.
- Comply with UKHSA policy and procedures.
- Prioritise, co-ordinate and organise specialist investigations and supervise the team workload.
- Maintain a positive attitude to the laboratory work and other members of the team.
- Ensure health, safety and welfare are prioritised and to demonstrate commitment to health, safety and welfare of self, staff and visitors and comply with relevant UKHSA health and safety policies.
- Escalate risks that cannot be controlled to the Technical Manager and Head of Operations.
- Notify management of accidents, near misses, dangerous situations and shortcomings in health and safety.
- Report any personal sickness in line with the UKHSA Sickness Absence management policy.
- Participate in a joint annual review of your work.
The above is only an outline of the tasks, responsibilities and outcomes required of the role. You will perform any other duties required by the line manager commensurate with grade.
The job description and person specification may be reviewed on an ongoing basis in accordance with the changing needs of the organisation.
You should maintain high professional standards by continuous professional development in accordance with any relevant professional registration or statutory requirements, keeping up to date with advances in Medical Microbiology while maintaining appropriate awareness of service provider requirements.
Essential criteria:
- Educated to BSc or MSc level in biological discipline
- Experience of diagnostic molecular biology testing and molecular methods
- Experience in managing quality in an accredited laboratory
- Experience in applying a range of standards, regulations and guidelines applicable to clinical laboratories such as ISO15189
- Familiar with electronic quality management software solutions
- Understanding of quality assurance principles and procedures
- Relevant experience in leading teams and/or projects
- Experience of working in a regulated environment with quality systems and knowledge of UKAS
- Evidence of success in efficient and effective project and programme participation/management
- Problem solving skills and ability to respond to sudden unexpected demands
- Ability to make decisions on difficult and contentious issues where there may be a number of courses of action
- Adaptability, flexibility and ability to cope with uncertainty and change
Desirable criteria:
- Registration with the Health & Care Professions Council (HCPC) as Biomedical Scientist
- Recent experience in a diagnostic or reference laboratory
- Experience of monitoring user satisfaction and liaising with customers
- Working knowledge of LIMS
- Previous experience and skills in project management and planning.
Selection Process Detail
This vacancy is using Success Profiles and will assess your Behaviours, Experience and Technical skills.
Stage 1: Application & Sift
Success Profiles
You will be required to complete an application form. You will be assessed on the listed 12 essential criteria, and this will be in the form of a:
- Application form (Employer/ Activity history section on the application)
- 1250 word supporting statement.
This should outline how your skills, experience, and knowledge, provide evidence of your suitability for the role, with reference to the essential criteria.
The Application form and supporting statement will be marked together.
Please note you will not be able to upload your CV. You must complete the application form in as much detail as possible. Please do not email us your CV. Longlisting:
In the event of a large number of applications we will longlist into 3 piles of:
- Meets all essential criteria
- Meets some essential criteria
- Meets no essential criteria
Those falling into the 'Meets all essential criteria' pile will progress to shortlisting.
Shortlisting:
In the event of a large number of applications we will shortlist on the following essential criteria:
- Educated to BSc or MSc level in biological discipline.
Desirable criteria may be used in the event of a large number of applications / large amount of successful candidates.
If you are successful at this stage, you will progress to interview.
Please do not exceed 1250 words. We will not consider any words over and above this number.
Feedback will not be provided at this stage.
Stage 2: Interview
Success Profiles
You will be invited to a remote interview.
Behaviours and Technical Skills will be tested at interview.
The Behaviours tested during the interview stage will be:
- Managing a Quality Service(Lead behaviour)
- Changing and Improving
- Communicating and Influencing
- Working at Pace
You will also be asked some technical based questions during the interview. These will be based on:
- The principles of quality management and of service delivery in clinical laboratories.
Interviews dates are yet to be confirmed.
Once this job has closed, the job advert will no longer be available. You may want to save a copy for your records.
Eligibility Criteria
Open to all external applicants (anyone) from outside the Civil Service (including by definition internal applicants).
Location
This role is being offered as hybrid working based at our Scientific Campus in Porton.We offer great flexible working opportunities at UKHSA and operate using a hybrid working model where business needs allow. This provides us with greater flexibility about how and where we work, to get the best from our workforce. As a hybrid worker, you will be expected to spend a minimum of 60% of your contractual working hours (approximately 3 days a week pro rata, (averaged over a month). If based at one of our scientific campuses, you will be required to have a minimum of a Counter Terrorism Check security vetting check as a minimum. For meaningful National Security Vetting checks to be carried out individuals need to have lived in the UK for a sufficient period of time.
Salary Bands
Civil Service SEO (National) £41,983 to £48,128 per annum, pro rataNHS AfC Band 7 £47,810 to £54,710per annum, pro rata
Candidates with HCPC registration will be appointed on NHS T&Cs at NHS AfC Band 7, candidates without HCPS registration will be appointed on Civil Service T&Cs at SEO grade.
Please note: If you are successful at interview, and are moving from another government department, NHS, or Local Authority, the relevant starting salary principles for level transfers or promotions will apply. Otherwise, roles are offered at the pay scale minimum for the grade, but in exceptional circumstances there may be flexibility if you are able to demonstrate you are already in receipt of an existing, higher salary. Pay increases are through the relevant annual pay award for the role and terms.
Security Clearance Level Requirement
Successful candidates must pass a disclosure and barring security check.
Successful candidates must meet the security requirements before they can be appointed. The level of security needed is Counter-terrorist Check.
For meaningful National Security Vetting checks to be carried out individuals need to have lived in the UK for a sufficient period of time. You should normally have been resident in the United Kingdom for the last 3 years as the role requiresCounter Terrorism Check (CTC) clearance. UK residency less than the outlined periods may not necessarily bar you from gaining national security vetting and applicants should contact the Vacancy Holder / Recruiting Manager listed in the advert for further advice.
