Medical Affairs QC Analyst NEW

Cambridge, Cambridgeshire
Oxford Gene Technology

OGT is a leading global provider of clinical and diagnostic genomic solutions. We believe in creating products and partnerships that enable clinicians to deliver personalised healthcare to patients and that empower clinical researchers to develop the next generation of precision medicines.

An opportunity has arisen in our Medical Affairs team for a Medical Affairs QC Analyst. This role offers a varied mix of hands on laboratory work and quality-focused administrative responsibilities, supporting key FISH and NGS processing activities.

What you’ll be doing for us:

• Responsible for an assigned proportion of FISH and NGS product testing
• Act as a subject expert in microscopy and NGS process for the purposes of product testing
• Adhering to documented procedures for all aspects of laboratory work, ensuring that all relevant information is recorded, products and samples are handled correctly, and that all necessary records and quality data are maintained.
• Responsible for an appropriate proportion of the quality management system, including procedures and audits.
• Oversee the smooth and efficient functioning of the laboratory, together with the other MA team members, including consumables, reagents, microscopes, equipment, and software.
• Contribute to the documentation and infrastructure of the department by providing input into internal protocols and implementation of CAPAs and improvements.
• Assist with investigations of product, process and equipment nonconformities, validations and process -efficiency initiatives.
• To comply with all site quality management systems, regulations and health and safety procedures (ISO 9001:2015, ISO 13485:2016, ISO 27001:2022, (EU) 2017/746 (IVDR), GCLP and Human Tissue Act (2004
• To complete any other tasks as commensurate with the level and nature of the post as delegated by the line manager.

What we are looking for in you:

• A bachelor’s degree in molecular biology, biochemistry, genetics, biotechnology, or similar subject is required, with a minimum of one-year laboratory experience
• Experience of working in a GLP/GMP environment
• Basic knowledge of FISH
• Basic Knowledge of NGS
• High accuracy and attention to detail
• Familiarity with working to defined protocols or standard operating procedures (SOPs)
• Able to work accurately and efficiently in a high-volume, process-driven, and protocol-driven environment
• Strong team work ethic and commitment to successfully deliver to tight deadlines are essential.
• Previous experience with FISH analysis is highly advantageous
• Experience in microscopy is advantageous
• Proficiency in molecular biology techniques is highly advantageous
• Experience in NGS based analysis is advantageous.

In return you will receive:

• Private Health Insurance
• Group Income Protection
• Group Life Assurance
• High Street Discount Scheme.

Application is via CV and a one-page covering letter outlining your suitability for the role, salary expectations and notice period.

Please note that we will need to establish your right to work during the recruitment process.