Quality Control Supervisor – Diagnostics

Quality Control Supervisor – Diagnostics
London based
Competitive Salary + Excellent Benefits

Do you have experience of quality control testing of IVD or diagnostics products?

Would you like to join a growing and successful organisation at the forefront of personalised diagnostic testing?

My client is a leading biotechnology / medical technology organisation in London that boasts an innovative technology platform that is set to revolutionise the availability of personalised genetic diagnostics to consumers. Following multiple approvals for medical/clinical diagnostics and due to ongoing development and expansion, they are looking to bring in an experienced Quality Control Supervisor – Diagnostics. The Quality Control Supervisor – Diagnostics will oversee all QC activities within the organisation, ensuing a quality and tested product is delivered to end users and all legal and quality obligations are met from a Quality Control perspective.

The Quality Control Supervisor – Diagnostics will take a lead role in the development of the QC department; writing and validating SOPs for QC testing and stability testing, ensuring QC data is checked and batches approved, ensuring stability trials of components and reagents are carried out accordingly, managing SOP changes, manging OOS and OOT data and CAPAs and ensuring QC input into the ISO13485 accreditation are met.

The Quality Control Supervisor – Diagnostics will also be responsible for leading a small team of QC Technicians, ensuring they are trained and motivated so that the testing schedules are met. You will also be responsible for the team’s personal development, appraisals, and team recruitment.

To be considered for the Quality Control Supervisor – Diagnostics role you will need the following skills and experience;

A life sciences BSc, MSc or PhD, or have equivalent experience.
Substantial, hands-on experience within Quality Control testing, ideally from the diagnostics / IVD industry.
Sound knowledge of PCR, qPCR, RT-PCR and ideally NGS (next generation sequencing).
Knowledge of the requirements under ISO 13485 for product testing in order to release batches
The ability to write and implement SOPs and stability protocols, with a pragmatic approach to working in an evolving company with a strong focus on product R&D. Being able to balance the needs of innovative product development within legal and quality frameworks.
The ability to lead and manage a small laboratory-based QC team
Have excellent communication skills, with the ability to converse at all levels in the organisation
Have excellent time management, prioritisation, and organisation skills

Key Words "Diagnostics, GLP, GMP, In-vitro diagnostics, ISO 13485, ISO 9001, IVD, Molecular Diagnostics, Next Generation Sequencing, NGS, PCR, QA, QC, QC Manager, QC Team Leader, qPCR, Quality Assurance, quality control scientist, Quality Control Supervisor, RT-PCR, Stability Studies"

This is a unique opportunity for an experienced Quality Control scientist within IVD or molecular diagnostics to take a lead role in a successful and innovative company, which has seen significant growth, year on year.