About the job

Job summary

GXP Quality Support Officer

Grade EO (National) - £25,976 - £30,264

UKHSA Porton Down

Permanent Contract

Are you passionate about ensuring quality and compliance in the field of life sciences? An exciting opportunity awaits you as a Quality Support Officer in our dynamic GXP Quality Team based in Porton. At UKHSA Porton, we are at the forefront of cutting edge research to advance scientific knowledge and improve public health. As a Quality Support Officer, you’ll play a crucial role in maintaining the highest standards of quality assurance.

As a Quality Support Officer, you will support the GxP Quality Assurance team, assisting with the maintenance of the GxP Quality management system. You will also perform other ad hoc administration tasks, from monitoring the Training Matrix to providing support for GxP training activities, you will handle diverse administrative duties. You will also assist the GxP eQMS Manager in maintaining and optimizing our new electronic Quality Management System. You’ll be part of the exciting transition from a paper-based system to the new eQMS.

UKHSA Porton – On-site

*Please be aware that this role can only be worked from within the UK and not overseas. Relocation expenses are not available.* 

Working Pattern – Full Time, Flexible Working

Job description

Responsibilities section:

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

• Provide support to the GxP QA Team to ensure that the quality system meets appropriate regulatory requirements e.g., Good Laboratory Practice (GLP), Good Clinical Practice (GCP) and Good Manufacturing Practice (GMP).
• To assist in the transition to, implementation and maintenance of the GxP electronic Quality Management System (eQMS) by carrying out administration of all controlled documents and other workflows.
• Assist GxP eQMS Manager in the provision of support and the delivery of training to system users on the use of the GxP eQMS.
• Confidentially manage controlled documents which contain sensitive information.
• To assist with the preparation of status reports (including KPI data) from the GxP Quality Management System.
• To provide administrative support to the GxP Quality Assurance department.
• To manage GxP QA spreadsheets, databases and the uploading of quality reports, technical agreements, and any other relevant quality documents.
• To provide support for customer audits and regulatory inspections.
• Write and update Standard Operating Procedures which describe the processes involved in activities carried out by the post holder.
• To monitor and update the GxP QA Training Matrix and assist with arranging training and managing access e-learning platform.

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 full duties and responsibilities attached

Person specification

Essential Criteria:

It is important through your application and Statement of Suitability of 1000 words that you give evidence and examples of proven experience of each of the essential criteria (for full details of all essential criteria please refer to the attached job description):

Essential

• Educated to NVQ3 level in a relevant subject or equivalent level of qualification or significant equivalent previous proven experience.
• Previous experience of working in an administrative environment using computerised data systems.
• Knowledge of Quality Management Systems administrative procedures or experience of working with GxP Quality Management Systems.
• Good working knowledge of Microsoft Office, including Word and Excel.
• Experience and knowledge of how to train others.

Desirable

• Experience of working in Good Laboratory Practice (GLP), Good Clinical Practice (GCP) or Good Manufacturing Practice (GMP) environment.
• Experience of writing and following written procedures (SOPs).

Benefits

Alongside your salary of £25,976, UK Health Security Agency contributes £7,013 towards you being a member of the Civil Service Defined Benefit Pension scheme. Find out what benefits a Civil Service Pension provides.

Things you need to know

Selection process details

Selection process details

STAGE 1 - APPLICATION & SIFT: 

You will be required to complete an application form. This will be assessed in line with the full list of essential criteria as detailed in the attached job description – 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:

• Communicating and influencing
• Working Together
• Managing a quality Service
• Delivery at pace

Expected Timeline:

Advert close: 23:55hrs on 21th February 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: 28th February 2024

Interviews: w/c 07th March 2024

Please note these dates could be subject to change.  

Eligibility Criteria

Open to all external applicants (anyone) from outside the Civil Service (including by definition internal applicants)

Nationality requirements

Appointments to roles within UKHSA will be made in accordance with the Civil Service nationality rules. These can be found at https://www.gov.uk/government/publications/nationality-rules This job is broadly open to the following groups:

• UK nationals
• Nationals of Commonwealth countries who have the right to work in the UK
• Nationals of the Republic of Ireland
• Nationals from the EU, EEA or Switzerland with settled or pre-settled status or who apply for either status by the deadline of the European Union Settlement Scheme (EUSS)
• Relevant EU, EEA, Swiss or Turkish nationals working in the Civil Service
• Relevant EU, EEA, Swiss or Turkish nationals who have built up the right to work in the Civil Service
• Certain family members of the relevant EU, EEA, Swiss or Turkish nationals

We recruit by merit on the basis of fair and open competition, as outlined in the Civil Service Commission's Recruitment Principles.

The Civil Service embraces diversity and promotes equal opportunities. As such, we run a Disability Confident Scheme (DCS) for candidates with disabilities who meet the minimum selection criteria.

The Civil Service welcomes applications from people who have recently left prison or have an unspent conviction. Read more about prison leaver recruitment.

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&C’s 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. 

Feedback will only be provided if you attend an interview or assessment.

Security

Successful candidates must undergo a criminal record check. People working with government assets must complete baseline personnel security standard (opens in new window) checks.

Nationality requirements

This job is broadly open to the following groups:

• UK nationals
• nationals of the Republic of Ireland
• nationals of Commonwealth countries who have the right to work in the UK
• nationals of the EU, Switzerland, Norway, Iceland or Liechtenstein and family members of those nationalities with settled or pre-settled status under the European Union Settlement Scheme (EUSS) (opens in a new window)
• nationals of the EU, Switzerland, Norway, Iceland or Liechtenstein and family members of those nationalities who have made a valid application for settled or pre-settled status under the European Union Settlement Scheme (EUSS)
• individuals with limited leave to remain or indefinite leave to remain who were eligible to apply for EUSS on or before 31 December 2020
• Turkish nationals, and certain family members of Turkish nationals, who have accrued the right to work in the Civil Service

Further information on nationality requirements (opens in a new window)

Working for the Civil Service

The Civil Service Code (opens in a new window) sets out the standards of behaviour expected of civil servants.

We recruit by merit on the basis of fair and open competition, as outlined in the Civil Service Commission's recruitment principles (opens in a new window). The Civil Service embraces diversity and promotes equal opportunities. As such, we run a Disability Confident Scheme (DCS) for candidates with disabilities who meet the minimum selection criteria.