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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 (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

• 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.

Further information

Grade: 5

Salary: £27,319 - £31,236 per annum. Potential to progress to £33,951 per annum through sustained exceptional contribution. 

Work arrangement: Full-time

Duration: Fixed Term Contract for 3 years. 

Line Manager: QC Lead

Direct Reports: QC Lead

Our website: https://www.sheffield.ac.uk/gtimc

This role is laboratory based on site at the Gene Therapy Innovation and Manufacturing Centre GTIMC, Sheffield Business Park, S9 1ZA. 

For informal enquiries about this job contact and for administration queries and details on the application process, contact the lead recruiter: Andrew Tomlin, Quality Control Lead: on a.tomlin@sheffield.ac.uk

Person specification

Our diverse community of staff and students recognises the unique abilities, backgrounds, and beliefs of all. We foster a culture where everyone feels they belong and is respected. Even if your past experience doesn't match perfectly with this role's criteria, your contribution is valuable, and we encourage you to apply. Please ensure that you reference the application criteria in the application statement when you apply.

Essential Criteria

• BSc in a scientific field
• Relevant work experience in an analytical capacity within gene therapy, biotechnology or other biological sciences.
• Working knowledge of GMP and the ability to apply standards as required for compliance in an advanced therapeutics manufacturing setting.
• Attention to detail and a proven ability to keep accurate and reliable records.
• Good interpersonal, verbal and written communication skills.
• Comfortable in a fast-paced operational environment with minimal direction.
• Ability to work independently as well as part of a multidisciplinary team to meet tight deadlines.
• Good organisational and time management skills.
• The ability to strictly adhere to written testing procedures, but also to think critically and propose changes to them where necessary.

Desirable Criteria

• Report writing skills and experience of delivering presentations.
• Experience working within a Quality Management System (QMS).

Next steps in the recruitment process

It is anticipated that the selection process will take place on Thursday 2nd October. This will consist of an interview and a practical assessment. We plan to let candidates know if they have progressed to the selection stage on the week commencing 29th September. Contact Laura Haslam (l.haslam@sheffield.ac.uk) if you require any reasonable adjustments.

Our vision and strategic plan

We are the University of Sheffield. This is our vision: sheffield.ac.uk/vision.

What we offer

• A minimum of 38 days annual leave including bank holiday and closure days (pro rata) with the ability to purchase more.
• Generous pension scheme.
• A wide range of discounts and rewards on shopping, eating out and travel.
• A variety of staff networks, providing opportunities for social interaction, peer support and personal development (for example, Race Equality, LGBT+, Women’s and Parent’s networks).
• Recognition Awards to reward staff who go above and beyond in their role.
• A commitment to your development access to learning and mentoring schemes; integrated with our Academic Career Pathways and Professional Services Shared Skills Framework.
• A range of generous family-friendly policies
• paid time off for parenting and caring emergencies
• support for those going through the menopause
• paid time off and support for fertility treatment and more

More details can be found on our benefits page: sheffield.ac.uk/jobs/benefits. 

We are a Disability Confident Employer. If you have a disability and meet the essential criteria you will be invited to interview.  

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.

We are a research university with a global reputation for excellence. Our ideas and expertise change the world for the better, making a real difference to society. We know that when people come together with different views, approaches and insights it can lead to richer, more creative and innovative teaching and research and the highest levels of student experience. Our University Vision (www.sheffield.ac.uk/vision) outlines our commitment to building a diverse community of staff and students that recognises and values the abilities, backgrounds, beliefs and ways of living for everyone.