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Job ID :
44074BR
Location :
United Kingdom - Bishops Stortford
:
Job Description

Company Information

About Thermo Fisher Scientific
Thermo Fisher Scientific Inc. (NYSE: TMO) is the world leader in serving science. Our mission is to enable our customers to make the world healthier, cleaner and safer. With revenues of $17 billion, we have approximately 50,000 employees and serve customers within pharmaceutical and biotech companies, hospitals and clinical diagnostic labs, universities, research institutions and government agencies, as well as in environmental and process control industries. We create value for our key stakeholders through three premier brands, Thermo Scientific, Fisher Scientific and Unity Lab Services, which offer a unique combination of innovative technologies, convenient purchasing options and a single solution for laboratory operations management. Our products and services help our customers solve complex analytical challenges, improve patient diagnostics and increase laboratory productivity. Visit www.thermofisher.com.

Job Description


Job Title: Quality Assurance Associate I
Reports To: Quality Manager
Group/Division: ThermoFisher Scientific / BioPharma Services Division
Career Band: 3
Job Track: Associate
Position Location: Fisher BioServices UK, Bishop’s Stortford
Number of Direct Reports 0
Day/Shift (if applicable): Core shift – 37.5 Hours per week


Position Summary:

This position is responsible for supporting the implementation of quality systems and ensuring that FBS UK is following EU GMP, MHRA/HTA/HFEA, ISO9001 and any other applicable regulations. This role is to ensure compliance to the Quality Management System and support the Quality Manager where required.

Key Responsibilities:

To become competent in the following areas. Please note that prior to gaining competency, these tasks must be performed under supervision of an expert:

  • SOP Management, including Document Control
  • Reviewing and where appropriate approving Trackwise PRs
  • Reviewing and where appropriate approving draft operational documentation. Performing Quality review of change controls
  • Responsible for status control of products/material
  • Assures compliance to ISO9001, company QMS and any other applicable regulations/standards
  • Assures compliance to MHRA regulations to ensure retention of MIA(IMP) and MS licenses
  • Assures compliance to HTA regulations to ensure retention of HTA license
  • Assures compliance to HFEA regulations to ensure retention of HFEA license
  • Performs required duties as an approved Archivist
  • Maintains QA metrics
  • Checking operational documentation for completeness, accuracy and adherence to Good Documentation Practices, where appropriate Quality approving documentation
  • Performs a QA related tasks as assigned by the Quality Manager
  • Performs QC functions as required
  • Travels as required
Minimum Requirements/Qualifications:

  • GMP experience is preferred


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