Job Summary

In this vital role within Tissue Services Department, you will lead and participate in the quality assurance aspects that support compliance with the Human Tissue (Quality and Safety for Human Application) Regulations 2007 (Q&S Regulations) as amended.

This role will be responsible for monitoring the efficient and effective quality system in place to ensure and monitor regulatory compliance. The responsibilities will be varied.

The quality assurance role is essential to the department to fully manage and ensure compliance against the HTA standards when carrying out any activity involving tissues and/or cells for Human Application (patient treatment) within clinical areas of QEHB.

You will be involved in undertaking audits and liaising with clinical and non clinical staff, key stakeholders from internal and external Trusts and participating in all inspections.

Undertaking audits, you will track and manage results and introduce corrective or preventative measures if needed. As a member of the Quality Assurance team, you will be involved in key decision-making and will be asked to contribute ideas for service improvements.

Main duties, tasks & skills required

Supporting, developing and maintaining compliance to all relevant licensing regulations and accreditation standards in partnership with key participants.

Assistance, implementation and compliance to all requirements of the Quality Management system.

Conduct and participate in training.

Prioritise and plan own workload, perform audits, physical stock management.

Monitoring and reviewing improvements and validation and verification exercises.

Work autonomously, with attention to detail and report and investigate incidents using the Trusts Incident Reporting System.

Line manages staff in the absence of the Operations Manager.

Provide cover for Tissue Services Administrator/support staff.

Supporting in purchase ordering and use of IT systems.

About us

We are recognised as one of the leading NHS Foundation Trusts in the UK. Our vision is to Build Healthier Lives, and we recognise that we need incredible staff to do this.

Our commitment to our staff is to create the best place for them to work, and we are dedicated to:

Investing in the health and wellbeing of our staff, including a commitment of offering flexible working where we can;
Offer our staff a wide variety of training and development opportunities, to support their personal and career development objectives.

UHB is committed to ensuring that our staff are treated fairly and feel that they belong, by creating a kind and inclusive environment. This is about equity of opportunity; removing all barriers, including discrimination and ensuring each individual member of staff reach their true potential, achieve their ambitions and thrive in their work. This is more than words. We are taking action. Our commitment to an inclusive culture is embedded at all levels of the organisation where every voice is heard, driven by our diverse and active staff networks, and at Board level by the Fairness Taskforce led by our CEO. We nurture a culture which empowers staff to challenge discriminatory behaviours and to enable people to bring their ‘whole self’ to a kinder, more connected and bold place to work.

University Hospitals Birmingham is a Smoke-Free premises hospital.

Person specification

Qualifications

Essential

Educated to degree level or equivalent professional qualification within the field of expertise or relevant work based evidenced experience.

Experience

Essential

* Experience in a regulated environment (HTA/ UKAS)

* Knowledge of human organ, tissue and cells, blood and medicines legislation across the UK

* Knowledge of diagnosis testing, donation of blood, tissues. Principles of the collection, storage and disposal of tissues, principles of organ donation and transplantation

* Knowledge of blood collection, testing, manufacturing and issuing processes

* Experience of working with information technology using Microsoft Office packages (Word, Excel and PowerPoint) or equivalent systems

* Experience of using IT systems to produce reports and correspondence which are timely, professional and accurate

* Understanding of Data Protection, Freedom of Information, UK Accreditation Service (UKAS), Good Laboratory Practise (GLP), Human Tissue Authority Regulations and Standards (HTA).

* Knowledge of good laboratory practise, and quality assurance practices

* Knowledge of Laboratory accreditation, relevant ISO and HTA and other appropriate European standards

* Knowledge of fault finding and trouble shooting

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.

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.

Closing Date: 27 March 2024

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