Job summary We are looking for the right individual to take on this permanent post, within the Quality section of the Vaccine Evaluation Unit. You will act as a Quality Assurance Practitioner who will support the Unit in providing scientific services to patients and clients as an aid in the evaluation of immunological responses to vaccines and microbiological disease. Main duties of the job The role will incorporate responsibilities associated with the Unit's facilities and laboratory equipment (design qualification, installation qualification, operation qualification and performance qualification) and delegated duties associated with the maintenance of the Unit's Quality Management System. You will possess an appropriate biological degree and have already had some appropriate laboratory experience. We are looking for an individual who can work well as part of a team and who has good communication/keyboard skills. The laboratory is accredited by CPA; and we actively encourage CPD activities and post-graduate qualifications. About us 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 Date posted 25 October 2024 Pay scheme Other Salary £25,976 to £30,264 a year per annum, pro rata Contract Permanent Working pattern Full-time, Part-time, Job share, Flexible working Reference number 919-JP-300502-EXT Job locations UKHSA Manchester Laboratory Manchester Royal Infirmary, Clinical Sciences Building, Oxford Road, Manchester M13 9WZ Job description Job responsibilities Clinical Governance To participate in and monitor Quality Assurance and Quality Control activities and assist the Unit in maintaining UKAS (United Kingdom Accreditation service) accreditation to ISO 15189, GCLP (Good Clinical Laboratory Practice) compliance, Good Clinical Practice (GCP) and European Medicines Agency (EMA) guidance. Quality Management To assist in the development of laboratory protocols, and where possible suggest improvements to, laboratory policies and procedures. To assist in the supervision of Senior Assistant Healthcare Scientists, Healthcare Scientist Practitioners, Quality Assurance Practitioner and visiting scientists and engineers to the Unit. To assist in the maintenance of the VEU Quality Systems. To assist with the management of equipment records, including servicing, calibration and validation arrangements. To assist and participate in external inspections. To assist in the issue, control and maintenance of relevant SOPs, policies and procedures. To undertake activities pertaining to the retention and archive of VEU documents. Education and Development To undertake on-going training and development and update Professional Development Plan, as required. To undertake the training, supervision and monitoring of Senior Assistant Healthcare Scientists, Healthcare Scientist Practitioners and students in accordance with the nature of a large teaching hospital. To present data at conferences nationally. Scientific To refer unusual or unfamiliar events to senior staff for action or advice. To use, maintain and calibrate equipment for the performance of specialist assays. To assist with, and where appropriate be responsible for, the development of new methods and implementation of new technology. To demonstrate appropriate competency to participate in Units out of hours service. During these periods the post holder will be a lone worker. The duties/responsibilities listed above describe the post as it is at present and is not intended to be exhaustive. The Job holder is expected to accept reasonable alterations and additional tasks of a similar level that may be necessary. Selection process details Stage 1: Application & Sift Competency based assessments You will be required to complete an application form. You will be assessed on the 11 essential criteria that have been selected from the job description, and this will be in the form of: an application form (Employer/ Activity history section on the application) a maximum 500 word Statement of Suitability. This should outline how you consider your skills, experience, and knowledge, provide evidence of your suitability for the role, with reference to the essential criteria. The application form and Statement of Suitability will be marked together. Unfortunately, late applications will not be considered. If you are successful at this stage, you will progress to interview & assessment. Please do not exceed 500 words. We will not consider any words over and above this number. Feedback will not be provided at this stage. Stage 2 - Interview If successful, you will be invited to a face-to-face interview. In exceptional circumstances, we may be able to offer a remote interview. There will be a written Technical Test as part of the interview process. Expected Timeline: Advert close: 23:55hrs on 8th November 2024 unfortunately, late applications will not be considered. Once this job has closed, the job advert will no longer be available. You may want to save a copy for your records. Interviews: w/c 25th November 2024. Please note these dates could be subject to change. Location This is a lab-based role located at Manchester Royal Infirmary. Please note Hybrid is not an option for this post. Eligibility Criteria Open to all external applicants (anyone) from outside the Civil Service (including by definition internal applicants) 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 Basic Personnel Security Standard / Counter-terrorist Check. You will be required to have a Counter Terrorism Check (CTC) 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. You should normally have been resident in the United Kingdom for the last 3 years as the role requires CTC clearance. In exceptional circumstances 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. For posts on UKHSA Civil Service terms and conditions, new entrants to the Civil Service are expected to start on the minimum of the pay band. For existing Civil Servants and roles advertised across government, the rules of transfer apply, i.e., level transfers move on current salary or the pay range minimum, transfers on promotion move to new pay range minimum or receive a 10% increase. Either case is determined by whichever is the highest. Job description Job responsibilities Clinical Governance To participate in and monitor Quality Assurance and Quality Control activities and assist the Unit in maintaining UKAS (United Kingdom Accreditation service) accreditation to ISO 15189, GCLP (Good Clinical Laboratory Practice) compliance, Good Clinical Practice (GCP) and European Medicines Agency (EMA) guidance. Quality Management To assist in the development of laboratory protocols, and where possible suggest improvements to, laboratory policies and procedures. To assist in the supervision of Senior Assistant Healthcare Scientists, Healthcare Scientist Practitioners, Quality Assurance Practitioner and visiting scientists and engineers to the Unit. To assist in the maintenance of the VEU Quality Systems. To assist with the management of equipment records, including servicing, calibration and validation arrangements. To assist and participate in external inspections. To assist in the issue, control and maintenance of relevant SOPs, policies and procedures. To undertake activities pertaining to the retention and archive of VEU documents. Education and Development To undertake on-going training and development and update Professional Development Plan, as required. To undertake the training, supervision and monitoring of Senior Assistant Healthcare Scientists, Healthcare Scientist Practitioners and students in accordance with the nature of a large teaching hospital. To present data at conferences nationally. Scientific To refer unusual or unfamiliar events to senior staff for action or advice. To use, maintain and calibrate equipment for the performance of specialist assays. To assist with, and where appropriate be responsible for, the development of new methods and implementation of new technology. To demonstrate appropriate competency to participate in Units out of hours service. During these periods the post holder will be a lone worker. The duties/responsibilities listed above describe the post as it is at present and is not intended to be exhaustive. The Job holder is expected to accept reasonable alterations and additional tasks of a similar level that may be necessary. Selection process details Stage 1: Application & Sift Competency based assessments You will be required to complete an application form. You will be assessed on the 11 essential criteria that have been selected from the job description, and this will be in the form of: an application form (Employer/ Activity history section on the application) a maximum 500 word Statement of Suitability. This should outline how you consider your skills, experience, and knowledge, provide evidence of your suitability for the role, with reference to the essential criteria. The application form and Statement of Suitability will be marked together. Unfortunately, late applications will not be considered. If you are successful at this stage, you will progress to interview & assessment. Please do not exceed 500 words. We will not consider any words over and above this number. Feedback will not be provided at this stage. Stage 2 - Interview If successful, you will be invited to a face-to-face interview. In exceptional circumstances, we may be able to offer a remote interview. There will be a written Technical Test as part of the interview process. Expected Timeline: Advert close: 23:55hrs on 8th November 2024 unfortunately, late applications will not be considered. Once this job has closed, the job advert will no longer be available. You may want to save a copy for your records. Interviews: w/c 25th November 2024. Please note these dates could be subject to change. Location This is a lab-based role located at Manchester Royal Infirmary. Please note Hybrid is not an option for this post. Eligibility Criteria Open to all external applicants (anyone) from outside the Civil Service (including by definition internal applicants) 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 Basic Personnel Security Standard / Counter-terrorist Check. You will be required to have a Counter Terrorism Check (CTC) 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. You should normally have been resident in the United Kingdom for the last 3 years as the role requires CTC clearance. In exceptional circumstances 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. For posts on UKHSA Civil Service terms and conditions, new entrants to the Civil Service are expected to start on the minimum of the pay band. For existing Civil Servants and roles advertised across government, the rules of transfer apply, i.e., level transfers move on current salary or the pay range minimum, transfers on promotion move to new pay range minimum or receive a 10% increase. Either case is determined by whichever is the highest. Person Specification Qualifications Essential BSc Hons in appropriate biological degree Experience Essential In depth understanding of quality procedures and control and relevant legal standards Basic scientific mathematics Skills for communication on complex information and administrative matters, requiring developed interpersonal and oral/ written communication skills Problem solving skills and ability to respond to sudden unexpected demands Skills for manipulating information Advanced keyboard skills, use of a range of software Able to work on own initiative, organising and prioritising own workload to set deadlines An ability to maintain confidentiality and trust Good time keeping Flexible approach to work Person Specification Qualifications Essential BSc Hons in appropriate biological degree Experience Essential In depth understanding of quality procedures and control and relevant legal standards Basic scientific mathematics Skills for communication on complex information and administrative matters, requiring developed interpersonal and oral/ written communication skills Problem solving skills and ability to respond to sudden unexpected demands Skills for manipulating information Advanced keyboard skills, use of a range of software Able to work on own initiative, organising and prioritising own workload to set deadlines An ability to maintain confidentiality and trust Good time keeping Flexible approach to work Disclosure and Barring Service Check This post is subject to the Rehabilitation of Offenders Act (Exceptions Order) 1975 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service (formerly known as CRB) to check for any previous criminal convictions. Certificate of Sponsorship Applications from job seekers who require current Skilled worker sponsorship to work in the UK are welcome and will be considered alongside all other applications. For further information visit the UK Visas and Immigration website (Opens in a new tab). From 6 April 2017, skilled worker applicants, applying for entry clearance into the UK, have had to present a criminal record certificate from each country they have resided continuously or cumulatively for 12 months or more in the past 10 years. Adult dependants (over 18 years old) are also subject to this requirement. Guidance can be found here Criminal records checks for overseas applicants (Opens in a new tab). Additional information Disclosure and Barring Service Check This post is subject to the Rehabilitation of Offenders Act (Exceptions Order) 1975 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service (formerly known as CRB) to check for any previous criminal convictions. Certificate of Sponsorship Applications from job seekers who require current Skilled worker sponsorship to work in the UK are welcome and will be considered alongside all other applications. For further information visit the UK Visas and Immigration website (Opens in a new tab). From 6 April 2017, skilled worker applicants, applying for entry clearance into the UK, have had to present a criminal record certificate from each country they have resided continuously or cumulatively for 12 months or more in the past 10 years. Adult dependants (over 18 years old) are also subject to this requirement. Guidance can be found here Criminal records checks for overseas applicants (Opens in a new tab). Employer details Employer name UK Health Security Agency Address UKHSA Manchester Laboratory Manchester Royal Infirmary, Clinical Sciences Building, Oxford Road, Manchester M13 9WZ Employer's website https://www.gov.uk/government/organisations/uk-health-security-agency (Opens in a new tab)