Microbiologist Role: Quality Assurance Specialist

3 weeks ago


Darlington, Darlington, United Kingdom CPI Full time

Job Summary:


CPI is seeking a highly skilled Microbiologist to join our team as a Quality Assurance Specialist. In this role, you will play a critical part in supporting the quality assurance environmental monitoring strategy for our GMP facilities, promoting and integrating quality into every aspect of our business.



About the Role:


As a Quality Assurance Specialist, you will be responsible for collecting, analyzing, and reporting data on environmental conditions to ensure our cleanrooms meet the classification as determined by ISO and Annex 1. You will work closely with manufacturing and quality teams to identify potential contamination risks and contribute to the development and execution of contamination control strategies for our facilities.



Your Key Responsibilities:



  • Maintain consistent and documented compliance with all relevant Safety, Health, and Environmental (SHE), Good Manufacturing Practice (GMP), Data Integrity (DI), quality, and best practice requirements.
  • Perform routine environmental monitoring of cleanrooms and manage outsourced EM activities in accordance with GMP guidelines, taking appropriate actions to manage deviations and OOS results.
  • Assure that Environmental Monitoring operations are conducted in compliance with facility procedures and regulatory guidance.
  • Support in the resolution of environmental issues to support the release of products.
  • Perform root cause investigations and quality risk assessments to GMP standards.
  • Support the development and execution of the control strategy and site master file for CPI Biologics GMP facilities to ensure they are current and appropriate to the activities being undertaken.
  • Undertake hygiene risk assessments for facility, utilities, and project-specific processes.
  • Support the technical transfer of projects into the GMP facility to ensure compliance to GMP requirements and the CPI Biologics control strategy.
  • Support regulatory and customer audits as a GMP SME for Environmental Monitoring.
  • Author, review, and approval of policies, SOPs, work instructions, and other quality documentation.


What We Offer:


CPI offers a competitive salary range of £45,000 - £60,000 per annum, depending on experience, plus a range of benefits including up to 36 days holiday, a generous pension scheme, life assurance, and flexible working options.



Requirements:


To be successful in this role, you will need to have a HNC or Foundation Degree level (or equivalent) in a Scientific/Engineering discipline, plus significant industrial experience at a senior level. Alternatively, a Degree level (or equivalent) in a Scientific/Engineering discipline, plus significant industrial experience, is also acceptable. You will also possess microbiology and/or environmental monitoring expertise in a GMP environment, with experience of operating within a GMP environment, applying routine systems for environmental monitoring activities.



Desirable Qualifications:


A Degree in Microbiology and Chartered status with a relevant professional institution are highly desirable.



About CPI:


CPI is a leading technology innovation centre, providing a range of services to support the growth of new and existing businesses. Our team of experts provides access to cutting-edge equipment, specialist facilities, and technical expertise to help businesses develop and commercialize new products and services.



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