Senior QC Scientist
2 weeks ago
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 releasee 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.
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