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