We are proud to be partnering again with one of our long-standing clients - an innovative and rapidly growing diagnostics organisation transforming precision medicine and companion diagnostics.
Following the successful completion of a CDx programme and device approval, the company is entering an exciting phase of expansion and is actively growing. Known for its collaborative culture, strong leadership, and genuine opportunities for progression, this is an excellent time to join a business scaling at pace.
They are now seeking a Medical Affairs QC Analyst to support critical laboratory and quality activities across FISH and NGS testing workflows.
The Role
This position offers a unique blend of hands-on laboratory work and quality-focused responsibilities, contributing directly to regulated diagnostic product testing and continuous improvement initiatives.
What You’ll Be Doing
* Perform an assigned proportion of FISH and NGS product testing
* Act as a subject matter contributor for microscopy and NGS processes related to product testing
* Follow documented laboratory procedures, ensuring accurate recording of data and correct handling of samples and products
* Maintain high-quality standards and ensure all records and quality data are compliant
* Support and maintain elements of the Quality Management System, including procedures and audits
* Help oversee day-to-day laboratory operations, including consumables, reagents, equipment, microscopes, and software
* Contribute to internal documentation, protocol development, CAPAs, and continuous improvement initiatives
* Assist with investigations relating to product, process, and equipment nonconformities
* Participate in validations and process-efficiency projects
* Ensure compliance with site regulations including ISO 9001, ISO 13485, ISO 27001, IVDR, GCLP, and the Human Tissue Act
* Support additional departmental activities as required
What We’re Looking For
Essential
* Bachelor’s degree in Molecular Biology, Genetics, Biotechnology, Biochemistry, or a related discipline
* Minimum 1 year of laboratory experience
* Experience working in a GLP or GMP environment
* Basic knowledge of FISH
* Basic knowledge of NGS
* Strong documentation and Good Documentation Practice
* High accuracy and attention to detail
* Experience working to SOPs and defined protocols
* Ability to work efficiently in a high-throughput, process-driven environment
* Strong teamwork mindset with the ability to meet deadlines
Desirable
* Hands-on FISH analysis experience
* Microscopy experience
* Strong molecular biology technical skills
* Experience with NGS-based analysis
Why Join?
* Join a company in major growth phase following regulatory and programme success
* Strong internal progression opportunities
* Collaborative, supportive culture
* Exposure to cutting-edge precision medicine and companion diagnostics
* Opportunity to make a real impact within a scaling organisation