Senior QC Scientist - IVD

Senior QC Scientist - IVD

Cambridge

Permanent

Scope of the role:

Part of the Production team and reporting to the Head of Reagent Development, this role is a great opportunity to work in close collaboration with both the Quality and Manufacturing teams. Core responsibilities will revolve around implementation and QC assessments for both incoming resources and consistent quality-driven release of company products.

Key responsibilities:

• Managing the availability and quality of the molecular diagnostic reagents required for the development protocols.
• Working collaboratively with the rest of the team to ensure the product portfolio meets the stringent quality and regulatory requirements required for release to the market.
• Work closely with the Production team to monitor the quality of incoming reagents and chemicals. Also to aliquot and store appropriately with relevant documentation and upload to the QMS.
• Ensure the reagents used undergo a robust QC test before being release to development scientists.
• Track and record QC pass and fail data.
• Working with stringent SOPs to ensure the wider ream is able to perform environmental monitoring.
• Work with respect to the ISO 13485 and FDA regulations that the business upholds.

Your background:

• Demonstrable recent experience of working in an ISO 13485/IVD environment with devices in development and reagents for in vitro diagnostics
• BSc or equivalent in Molecular Biology or a similar, relatable discipline.
• Practical bench skills with PCR methods.
• Good understanding of the expectations of working under formal quality systems such as ISO 13485 and FDA regulations.
• You come from and are seeking a bench-based laboratory role.
• You bring an enthusiastic and thorough approach, with excellent attention to detail and a good team ethos.

The role comes with an enviable selection of company benefits including (but not limited to): 12% company pension contribution, private health insurance, enhanced mat/paternity pay, electric car lease scheme, free lunch and refreshments provided daily, onsite gym and trim-trail.

Carbon60, Lorien & SRG - The Impellam Group STEM Portfolio are acting as an Employment Business in relation to this vacancy.