Senior Quality Control Scientist

2 weeks ago

Cambridge, United Kingdom LEX Diagnostics Limited Full time

LEX Diagnostics is currently hiring for a Senior Quality Control Scientist to become part of our Production team. Reporting directly to the Head of Reagent Development, you'll work in close collaboration with the Head of Manufacturing and Head of Quality. Your primary responsibilities will include implementing and conducting quality control assessments for incoming materials as well as ensuring the smooth release of LEX products.

LEX Diagnostics is an ambitious, well-supported point-of-care diagnostics company with a bold vision. We believe that fast, accessible molecular diagnostics will have a fundamental impact on how infectious diseases are managed at point of care and beyond. Our cutting-edge technology is uniquely able to address this challenge and we are commercialising it with partners who share our ambition. You can read more about LEX here.

As the Senior Quality Control Scientist, you’ll play a pivotal role in managing the availability and quality of the molecular diagnostic reagents essential for our development processes. You’ll work closely with the team to establish and execute the quality control protocols to support and ensure that our products meet regulatory standards and are ready for market release.

 

Responsibilities include:

  • Collaborate with the Production team to ensure incoming reagents and chemicals are received, aliquoted, stored with documentation and uploaded to the Quality Management System (QMS) as required.
  • Verify that the RT-PCR reagents manufactured by LEX undergo a thorough quality control assessment before being released to the development teams.
  • Monitor and report on QC pass/fail metrics.
  • Support the wider biology team in performing environmental monitoring in line with the requirements of Standard Operating Procedures (SOP’s).
  • Follow all requirements of working in an ISO 13485/FDA regulated environment.
  • Adhere to all company policies and procedures, prioritising safety in the workplace, and promptly reporting any accidents or incidents.

Requirements

Following skills and experience required to be successful in this role:

  • Previous experience in QC for In Vitro Diagnostic (IVD) devices and or reagents within an ISO13485/FDA regulated environment.
  • Batchelors degree in Molecular biology or similar (or equivalent experience).
  • Hands on experience of PCR and understanding of underlying principles.
  • Familiarity with operating under formal quality systems and practices, such as ISO13485 and FDA regulations.
  • Enjoys being hands-on and working within the Biolabs.
  • Highly motivated and detail orientated.
  • Practical experience within the Life Science industry would be beneficial.

Benefits

LEX Diagnostics is part of TTP Group, an employee-owned business. It operates from green surroundings in Melbourn, less than 10 miles south of Cambridge. TTP Group takes a long-term approach to investment and has been at the forefront of point-of-care diagnostics for over 20 years. Drawing upon the expertise of its consultants in the Life Science sector, and the management experience of a company with a 30-year track record of developing breakthrough technology and creating ambitious tech businesses, TTP Group invested core IP and staff into LEX in 2020.

Our benefits include

  • Annual profit-related bonus
  • Employer pension contribution of 12% of pensionable pay
  • Private medical insurance for employees and dependants
  • Free lunch and all-day refreshments
  • Life insurance worth 6 x salary
  • 25 days holiday with the option to carry over or bring forward 5 days
  • Enhanced maternity and paternity leave, with the option to return part-time for a year
  • Electric car leasing scheme
  • Cycle to work scheme
  • Public Transport Season ticket loan
  • A wide range of social clubs and activities including squash, Zumba, yoga, arts and crafts and even our own rock band
  • Local sports facilities and theatre discounts and memberships as well as our own onsite gym to use

This is an exciting opportunity within the LEX Diagnostics team and to help and support us with achieving our goal to commercialisation. If you’re looking to join a diverse and growing team, then apply now

Every application will receive a response.

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