UK Health Security Agency

Quality Officer

Information:

This job is now closed

Job summary

Quality Officer

Grade: HEO National - £30,473-£37,215

Porton Down; On site

FTC Contract Until 31 Mar 2025

At Porton, the Research and Evaluation department consists of about 300 staff members, who conduct various research activities, such as high containment level work. The department's work encompasses a wide range of projects that involve the development and evaluation of interventions for various infectious diseases, such as SARS-CoV-2, TB, meningitis, anthrax and plague. The department also has a test facility that performs regulated studies in accordance with GLP, GCP and GMP standards. Furthermore, the department carries out both fundamental and applied research to understand infectious diseases and produces several healthcare products, such as vaccines and therapeutics.

Working Pattern: Porton Down 5 days per week. Full Time, Flexible Working 37.5 hours per week

Main duties of the job

This position belongs to the Quality Assurance Function. The position holder will be part of the independent Quality Assurance support for GxP regulated test facilities.

About us

Working for the UKHSA:

For more information on the UKHSA please visit: UK Health Security Agency - GOV.UK (www.gov.uk)

Benefits

  • Learning and development tailored to your role
  • An environment with flexible working options
  • A culture encouraging inclusion and diversity
  • A Civil Service pension with an average employer contribution of 27%
  • Range of health and wellbeing support

Any move to UKHSA from another employer will mean you can no longer access childcare vouchers. This includes moves between government departments. You may however be eligible for other government schemes, including Tax Free Childcare. Determine your eligibility at Childcare Choices | 30 Hours Free Childcare, Tax-Free Childcare and More | Help with Costs | GOV.UK

Details

Date posted

15 December 2023

Pay scheme

Other

Salary

£30,473 to £37,215 a year Per Anumn

Contract

Fixed term

Duration

6 months

Working pattern

Full-time, Flexible working

Reference number

UKHSA00392

Job locations

Porton Down

Porton Down, Sailsbury

SP4 0JG


Job description

Job responsibilities

The job holder will be required to carry out the following responsibilities, activities and duties:

  • Assist in the delivery and maintenance of GxP training, QA documentation control, change control and risk assessment quality processes.
  • Deliver GxP Training to meet quality, business and regulatory requirements.
  • Liaise with stakeholders to ensure appropriate QA support is provided.
  • Undertake assigned audits as part of the GxP internal audit programme including conducting QA reviews/ audits on study data, study records, GxP laboratories, supporting areas and critical suppliers of services and material.
  • Contribute to writing key quality documents e.g. Quality Reports, Risk Assessments, Technical Agreements and Standard Operating Procedures etc.
  • Undertake the review and approval of non-conformances, CAPA reports and related investigations, change controls and supplier approval questionnaires.
  • Assist GxP Test Facilities areas, Test Facilities Management and the Quality Team in preparation for, and during customer audits and regulatory inspections.
  • Perform any other duties required by the Line Manager commensurate with grade.
  • Undertake work in accordance with the UKHSAs risk management systems, policies and procedures, applicable quality systems (including current GLP, GCP and GMP regulations), H&S Laboratory Precautions Handbook and site wide UKHSA policies and procedures.
  • To fulfil the requirements of UKHSA Values and Behaviours commensurate with grade.

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.

Please see job description attached for full list of responsibilities and duties.

It is important through your application and Statement of Suitability of 1500 words that you give evidence and examples of proven experience of each of the following criteria:

Essential Criteria:

  • Educated to degree level in a relevant subject (i.e. Biological Sciences) or equivalent level of experience of working at a similar level in specialist area
  • Understanding of the Good Manufacturing Practice, Good Laboratory Practice and/or Good Clinical Practice regulations and experience of having worked to one or more of these regulations.
  • Good knowledge and preferably practical familiarity with relevant laboratory techniques and safe working practices.
  • Ability to analyse and interpret complex information, evaluate issues and recommend an appropriate course to line manager.
  • Excellent computer literacy skills with good knowledge of MS office and ability to produce accurate documentation and manipulate and present information effectively.
  • Ability to plan own work independently and within teams. Can work on own initiative and organize own workload, is self-motivated with a meticulous attention to detail

Desirable Criteria:

  • Training/experience in Quality Management Systems relevant to this post (e.g. CAPA, change control, risk assessment, document control)
  • Skills for communication on complex matters and difficult situations, requiring persuasion and influence. Ability to maintain good working relationships with colleagues.

Selection process details

STAGE 1 - APPLICATION & SIFT:

You will be required to complete an application form. This will be assessed in line with the advertised essential criteria please do provide evidence of how you meet this.

If you are successful at this stage, you will progress to an interview.

STAGE 2 INTERVIEW

This competition will involve an interview by video.

As part of the process, candidates will be invited to interview which will involve an in-depth discussion of your previous experience and professional competence in relation to the criteria set out in the Person Specification.

Your Statement of Suitability should outline your skills, experience, and achievements, providing evidence of your suitability for the role, with reference to the essential criteria (outlined in the person specification section).

You will also be asked to provide information within the Employer/ Activity history section of the application form. This is equivalent to the information you would provide on a CV, setting out your career history.

The Success Profiles framework will be used to assess and recruit the most suitable candidate. The following behaviours will be used at the interview:

  • Changing and improving
  • Making Effective Decisions
  • Working together
  • Communicating and influencing

Technical:

  • Ability to perform & report findings from quality audits of laboratories, data and study reports.
  • Knowledge of investigating and managing non-conformances and CAPA.
  • Ability to provide face-to-face training as classroom sessions or workshops.
  • Knowledge and understanding of working to GxP regulations.

Expected Timeline:

Advert close: 23:55hrs on 1st Jan 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.

Shortlist: TBC

Interviews: w/c TBC

Please note these dates could be subject to change.

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. People working with government assets must complete Basic Personnel Security Standard checks.

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.

Please Note

This role is to be appointed under Civil Service Terms & Conditions. Full details on the T&Cs are found https://www.ukhsa.reed.com/

Are you already a civil servant, or employed by a Civil Service Commission accredited public body? Please state home department on your application form.

Do you meet the nationality requirements for this post? https://www.ukhsa.reed.com/

Complaint process:

The law requires that selection for appointment to the Civil Service is on merit on the basis of fair and open competition as outlined in the Civil Service Commission's Recruitment Principles. If you feel your application has not been treated in accordance with the Recruitment Principles, and you wish to make a complaint, in the first instance, you should contact UKHSA Public Accountability Unit via email:Complaints1@ukhsa.gov.uk. If you are not satisfied with the response you receive from the Department, you can contact the Civil Service Commission: Visit the Civil Service Commission website.

Job description

Job responsibilities

The job holder will be required to carry out the following responsibilities, activities and duties:

  • Assist in the delivery and maintenance of GxP training, QA documentation control, change control and risk assessment quality processes.
  • Deliver GxP Training to meet quality, business and regulatory requirements.
  • Liaise with stakeholders to ensure appropriate QA support is provided.
  • Undertake assigned audits as part of the GxP internal audit programme including conducting QA reviews/ audits on study data, study records, GxP laboratories, supporting areas and critical suppliers of services and material.
  • Contribute to writing key quality documents e.g. Quality Reports, Risk Assessments, Technical Agreements and Standard Operating Procedures etc.
  • Undertake the review and approval of non-conformances, CAPA reports and related investigations, change controls and supplier approval questionnaires.
  • Assist GxP Test Facilities areas, Test Facilities Management and the Quality Team in preparation for, and during customer audits and regulatory inspections.
  • Perform any other duties required by the Line Manager commensurate with grade.
  • Undertake work in accordance with the UKHSAs risk management systems, policies and procedures, applicable quality systems (including current GLP, GCP and GMP regulations), H&S Laboratory Precautions Handbook and site wide UKHSA policies and procedures.
  • To fulfil the requirements of UKHSA Values and Behaviours commensurate with grade.

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.

Please see job description attached for full list of responsibilities and duties.

It is important through your application and Statement of Suitability of 1500 words that you give evidence and examples of proven experience of each of the following criteria:

Essential Criteria:

  • Educated to degree level in a relevant subject (i.e. Biological Sciences) or equivalent level of experience of working at a similar level in specialist area
  • Understanding of the Good Manufacturing Practice, Good Laboratory Practice and/or Good Clinical Practice regulations and experience of having worked to one or more of these regulations.
  • Good knowledge and preferably practical familiarity with relevant laboratory techniques and safe working practices.
  • Ability to analyse and interpret complex information, evaluate issues and recommend an appropriate course to line manager.
  • Excellent computer literacy skills with good knowledge of MS office and ability to produce accurate documentation and manipulate and present information effectively.
  • Ability to plan own work independently and within teams. Can work on own initiative and organize own workload, is self-motivated with a meticulous attention to detail

Desirable Criteria:

  • Training/experience in Quality Management Systems relevant to this post (e.g. CAPA, change control, risk assessment, document control)
  • Skills for communication on complex matters and difficult situations, requiring persuasion and influence. Ability to maintain good working relationships with colleagues.

Selection process details

STAGE 1 - APPLICATION & SIFT:

You will be required to complete an application form. This will be assessed in line with the advertised essential criteria please do provide evidence of how you meet this.

If you are successful at this stage, you will progress to an interview.

STAGE 2 INTERVIEW

This competition will involve an interview by video.

As part of the process, candidates will be invited to interview which will involve an in-depth discussion of your previous experience and professional competence in relation to the criteria set out in the Person Specification.

Your Statement of Suitability should outline your skills, experience, and achievements, providing evidence of your suitability for the role, with reference to the essential criteria (outlined in the person specification section).

You will also be asked to provide information within the Employer/ Activity history section of the application form. This is equivalent to the information you would provide on a CV, setting out your career history.

The Success Profiles framework will be used to assess and recruit the most suitable candidate. The following behaviours will be used at the interview:

  • Changing and improving
  • Making Effective Decisions
  • Working together
  • Communicating and influencing

Technical:

  • Ability to perform & report findings from quality audits of laboratories, data and study reports.
  • Knowledge of investigating and managing non-conformances and CAPA.
  • Ability to provide face-to-face training as classroom sessions or workshops.
  • Knowledge and understanding of working to GxP regulations.

Expected Timeline:

Advert close: 23:55hrs on 1st Jan 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.

Shortlist: TBC

Interviews: w/c TBC

Please note these dates could be subject to change.

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. People working with government assets must complete Basic Personnel Security Standard checks.

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.

Please Note

This role is to be appointed under Civil Service Terms & Conditions. Full details on the T&Cs are found https://www.ukhsa.reed.com/

Are you already a civil servant, or employed by a Civil Service Commission accredited public body? Please state home department on your application form.

Do you meet the nationality requirements for this post? https://www.ukhsa.reed.com/

Complaint process:

The law requires that selection for appointment to the Civil Service is on merit on the basis of fair and open competition as outlined in the Civil Service Commission's Recruitment Principles. If you feel your application has not been treated in accordance with the Recruitment Principles, and you wish to make a complaint, in the first instance, you should contact UKHSA Public Accountability Unit via email:Complaints1@ukhsa.gov.uk. If you are not satisfied with the response you receive from the Department, you can contact the Civil Service Commission: Visit the Civil Service Commission website.

Person Specification

Essential

Essential

  • oEducated to degree level in a relevant subject (i.e. Biological Sciences) or equivalent level of experience of working at a similar level in specialist area
  • oUnderstanding of the Good Manufacturing Practice, Good Laboratory Practice and/or Good Clinical Practice regulations and experience of having worked to one or more of these regulations.
  • oGood knowledge and preferably practical familiarity with relevant laboratory techniques and safe working practices
  • oAbility to analyse and interpret complex information, evaluate issues and recommend an appropriate course to line manager
  • oExcellent computer literacy skills with good knowledge of MS office and ability to produce accurate documentation and manipulate and present information effectively.
  • oAbility to plan own work independently and within teams. Can work on own initiative and organize own workload, is self-motivated with a meticulous attention to detail

Desirable

  • oTraining/experience in Quality Management Systems relevant to this post (e.g. CAPA, change control, risk assessment, document control)
  • oSkills for communication on complex matters and difficult situations, requiring persuasion and influence. Ability to maintain good working relationships with colleagues.
Person Specification

Essential

Essential

  • oEducated to degree level in a relevant subject (i.e. Biological Sciences) or equivalent level of experience of working at a similar level in specialist area
  • oUnderstanding of the Good Manufacturing Practice, Good Laboratory Practice and/or Good Clinical Practice regulations and experience of having worked to one or more of these regulations.
  • oGood knowledge and preferably practical familiarity with relevant laboratory techniques and safe working practices
  • oAbility to analyse and interpret complex information, evaluate issues and recommend an appropriate course to line manager
  • oExcellent computer literacy skills with good knowledge of MS office and ability to produce accurate documentation and manipulate and present information effectively.
  • oAbility to plan own work independently and within teams. Can work on own initiative and organize own workload, is self-motivated with a meticulous attention to detail

Desirable

  • oTraining/experience in Quality Management Systems relevant to this post (e.g. CAPA, change control, risk assessment, document control)
  • oSkills for communication on complex matters and difficult situations, requiring persuasion and influence. Ability to maintain good working relationships with colleagues.

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

Porton Down

Porton Down, Sailsbury

SP4 0JG


Employer's website

https://www.gov.uk/government/organisations/uk-health-security-agency (Opens in a new tab)

Employer details

Employer name

UK Health Security Agency

Address

Porton Down

Porton Down, Sailsbury

SP4 0JG


Employer's website

https://www.gov.uk/government/organisations/uk-health-security-agency (Opens in a new tab)

Employer contact details

For questions about the job, contact:

Senior RPO Talent Partner

Amrita Jetwani

Amrita.Jetwani@reed.com

Details

Date posted

15 December 2023

Pay scheme

Other

Salary

£30,473 to £37,215 a year Per Anumn

Contract

Fixed term

Duration

6 months

Working pattern

Full-time, Flexible working

Reference number

UKHSA00392

Job locations

Porton Down

Porton Down, Sailsbury

SP4 0JG


Supporting documents

Privacy notice

UK Health Security Agency's privacy notice (opens in a new tab)