Quality Control Technician

Overview

Reporting to the Quality Control (QC) Lead, the QC Technician is a fundamental part of QC operations at the Gene Therapy Innovation and Manufacturing Centre (GTIMC), performing routine analysis of both products and environmental samples. The QC technician will perform a range of analytical assays, along with the routine microbiological monitoring of the facility. 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 will include a cutting-edge GMP 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

• Perform analytical assays such as PCR and ELISA, demonstrating a consistently high level of competence in QC methods.
• Maintain quality control documentation to GMP standards.
• Contribute to the development, writing and implementation of standard operating procedures for the GTIMC.
• Environmental monitoring - sampling and submission of samples to third-party providers, then subsequent interpretation of results.
• Assisting with the development of internal microbiology facilities.
• 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.
• Understanding of cleanrooms and their associated regulation and regulators.
• Managing laboratory reagents and consumables through stock checks etc.
• Maintaining and calibrating laboratory equipment and instruments within the QC laboratories, ensuring all equipment remains operational within its validated parameters.
• Check and release of incoming materials.
• Carrying out investigations and root cause analysis of exceptions, deviations and out of specification results.
• Participating in internal and external audits.
• Maintain the operational cleanliness of the QC laboratories in line with Good Laboratory Practice (GLP) and GTIMC housekeeping procedures.
• Carry out other duties, commensurate with the grade and remit of the post.

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