Quality Assurance (QA) Specialist at University of Sheffield

Faculty: Faculty of Medicine Dentistry and Health

Contract Type: Fixed-term for 3 years

The Gene Therapy Innovation & Manufacturing Centre (GTIMC) Gene therapy is a promising treatment option for a number of diseases that currently have no other cures.

The GTIMC at Sheffield is one of three cutting-edge hubs in the UK dedicated to advancing the clinical development of new genetic treatments options for millions of patients with life-threatening diseases.

The Sheffield Hub, which is the first in the north of England, is part of an £18 million network created by LifeArc and the Medical Research Council (MRC), with support from the Biotechnology and Biological Sciences Research Council (BBSRC).

The GTIMC is located at the University of Sheffield’s Innovation District, close to the centres of Sheffield and Rotherham and within easy reach of major transportation corridors and regional shopping and entertainment complexes.

The centre will include a cutting-edge GMP (good manufacturing practice) facility that will support gene therapy projects emerging from universities across the UK, helping novel medicines progress to clinical trials. In this way, it will play its part in increasing the number of treatments available for genetic diseases that currently have no cure.

Role Description

This is an opportunity to assist in the development of a brand-new gene therapy facility, in a position that will allow you to develop and grow the quality management system. Assisting the QA manager in the creation and implementation of quality standards, procedures, and guidelines into GTIMC to ensure our products meet regulatory requirements and established quality criteria. Working collaboratively with departments in GTIMC, such as production, quality control (QC), research and development (R&D), the QA specialist will play a pivotal role addressing and resolving quality-related issues promptly. Foster strong cross-functional collaboration to drive quality improvements and ensure seamless integration of quality systems across the GTIMC site.

The QA specialist will be responsible for investigating and analysing quality issues, deviations, and non-conformances in production and QC processes to determine root causes. Implementing robust corrective and preventive actions (CAPA) to prevent recurrence and continuously improve quality systems.

As part of the sites development a key part of the role will be to identify areas for process improvement and recommend corrective actions to enhance efficiency, reduce errors, and improve overall quality performance. Ensuring compliance with industry regulations, such as Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP).

The University We’re one of the best not-for-profit organisations to work for in the UK. The University’s Total Reward Package includes a competitive salary, a generous Pension Scheme and annual leave entitlement, as well as access to a range of learning and development courses to support your personal and professional development.

To find out what makes the University of Sheffield a remarkable place to work, watch this short film: www.youtube.com/watch?v=7LblLk18zmo, and follow @sheffielduni and @ShefUniJobs on Twitter for more information.

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