QC Specialist (Microbiology)

Thermo Fisher Scientific Cramlington, England

About the Job

When you’re part of Thermo Fisher Scientific, you’ll do challenging work, and be part of a team that values performance, quality and innovation. As part of a successful, growing global organization you will be encouraged to perform at your best. With revenues of $25 billion and the largest investment in R&D in the industry, we give our people the resources and opportunities to make significant contributions to the world.

Position Summary:

The primary function of this role is to ensure Microbiological testing and associated investigations and reports are completed in a timely manner. This role will provide QC along with others departments any guidance required relating to microbial issues.

Preferred education & experience

Microbiology degree / Microbiology experience within a pharmaceutical or laboratory environment.

Key skills & abilities:

  • To perform microbiological testing including Bioburden, growth promotion and identification of Micro- organisms.
  • To ensure all Microbiological procedures reflect current practice and comply with current USP/ EP requirements.
  • To direct the routine Environmental Monitoring program for all Cleanrooms and LAFs on the Cramlington site.
  • Perform reviews of environmental monitoring data writing quarterly report summaries and presenting findings to management on site.
  • Prepare Environmental Monitoring Risk Assessments and Performance Qualifications as and when required as part of Cleanroom validations and increasing production lines.
  • To perform any microbial investigations required that may result from routine EM, testing, validations or customer complaints.
  • To assist with validation testing of QC procedures and to assist the Validation Specialist in testing of validation samples.
  • To ensure the timely and accurate completion and filing of QC records, including the maintenance of QC databases.
  • To ensure that the QC laboratories and other QC working areas are maintained in a tidy state.
  • To ensure that stock levels of QC materials are effectively and efficiently maintained.
  • To provide guidance and support to all departments related to microbial issues as necessary.
  • Working knowledge of Excel & Microsoft Word (Computer literacy & basic keyboard skills)
  • To accept general & personal responsibilities for Health & Safety on site in compliance with UK Legislation and the Company’s Health & Safety Management System.
  • To perform any other duties as may be reasonably require

At Thermo Fisher Scientific, each one of our 75,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer.