Total 2 Senior Executive level Quality Assurance / Control job vacancies in CB2 3HH

Temporary Senior QC Scientist - Clinical Laboratory

Cambridge

11 week assignment beginning early July

Monday-Friday

£15-18 per hour

Scope of the role:

Your responsibility is for the Quality Control of the specialist in-house and purchased reagents and consumables of a busy clinical laboratory.

Core duties:

• Working within quality control matrix and protocols to ensure the smooth operation of both routine QC and unique QC testing for the company's IVD product, as well as continuous improvement behaviours.

• Working closely with Tech Transfer and Product Development in order to oversee the QC approach and support with new and existing analytical methods in addition to helping out with validation and verification and transfer activities.

• Investigating and resolving any issues with availability or performance of reagents and consumables, including: root cause analysis, impact assessment and putting in place corrective and preventative actions.

• Taking responsibility for timely reagent and consumable testing and analysis according to the established SOPs in order to support the wider Lab Operations team.

Your background:

• BSc/MSc or equivalent in a Life Science discipline

• Proven laboratory experience working with biochemical or molecular assays in addition to demonstrable ability to troubleshoot issues which impact reagent performance

• It would be a strong benefit to have knowledge of NGS and molecular testing methods

• Good appreciation of the regulatory requirements for a clinical laboratory (ISO 15189) and IVD, ISO 13485

• Good written and verbal communication skills, and able to work effectively in a busy and demanding laboratory environment

If you are open to a temporary assignment for the period noted above and bring the necessary skillset and background required, then please apply by attaching your CV in Word.

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

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.