QA Specialist

University of Sheffield; Sheffield; On-site; GBP 25,000 - 40,000; Full time

Job summary

An academic institution in Sheffield is seeking a Quality Assurance Specialist to support compliance with regulatory requirements for gene therapies. Responsibilities include developing quality systems, coordinating audits, and improving QA processes. Candidates should have a relevant degree and experience in a GMP environment. This position plays a critical role in ensuring product quality and patient safety in a leading-edge facility.

Qualifications

• Experience in quality assurance or validation in a GMP environment.
• Familiarity with regulatory guidelines such as GMP and GLP.
• Strong organizational and documentation skills.

Responsibilities

• Assist in developing quality systems and documentation.
• Coordinate cross-functional teams for compliance.
• Investigate and resolve quality issues.

Skills

Regulatory compliance

Quality assurance

Document control

Cross-functional collaboration

Problem-solving

Education

Relevant degree in life sciences or related field

Job description

Overview

The Quality Assurance (QA) Specialist will play a key role in supporting the QA team to ensure compliance with regulatory requirements related to the manufacture of gene therapies at the GTIMC facility. This position will contribute to maintaining MHRA inspection readiness and, once licensed, will support ongoing compliance to ensure the highest standards of product quality and patient safety.

Led by Professor Mimoun Azzouz, The GTIMC at Sheffield is dedicated to advancing the clinical development of new genetic treatments options for millions of patients with life-threatening diseases. The centre includes a purpose built GMP (good manufacturing practice) facility that will support gene therapy projects emerging from universities across the UK, helping novel medicines progress to clinical trials. The facility will utilise highly efficient processes to manufacture clinical grade adeno-associated viruses (AAV) and provide all the necessary quality assurance and regulatory certification for human trials at NHS hospital sites.
Located at the University of Sheffield's Innovation District, the GTIMC is close to the centres of Sheffield and Rotherham and within easy reach of major transportation corridors and regional shopping and entertainment complexes.

Main duties and responsibilities

• Assist in the development, implementation, and maintenance of quality systems, including document control, change control, deviation management, and risk assessment.
• Coordinate with cross-functional teams to ensure compliance with applicable regulatory guidelines, including but not limited to GMP, GLP, and other relevant quality standards.
• Collaborate with manufacturing and analytical teams to investigate and resolve product-related quality issues.
• Develop and implement corrective and preventive actions (CAPAs) to address identified non-compliance issues.
• Assist in the creation, review, approval, and maintenance of Standard Operating Procedures (SOPs), batch records, validation protocols, and other quality documentation.
• Assist and conduct internal audits and inspections to verify compliance with regulatory requirements and internal quality procedures.
• Ensure that all documentation is accurate, up-to-date, and readily accessible to relevant personnel.
• Support the investigation and resolution of customer complaints, deviations, and out-of-specification results.
• Identify opportunities for QA process improvement and collaborate with relevant stakeholders to implement quality enhancements.
• Participate in quality-related projects, including validation studies, process improvements, and risk assessments.
• To work as part of the wider GTIMC team, providing support as required to the other teams across the GTIMC facility as we work towards MHRA licensing.
• Understand cleanrooms and their associated regulation and regulators.
• Undertaking other tasks relating to the GTIMC as requested by the post's line manager.
• As a member of staff, you will be encouraged to make ethical decisions in your role, embedding the University sustainability strategy into your working activities wherever possible.
• Carry out other duties, commensurate with the grade and remit of the post.