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Job ID :
Location :
United Kingdom - Basingstoke
Job Description
Job Title: Senior Quality Assurance (QA) Specialist
Location: Basingstoke
Working hours: 35 hours per week including an early finish on Fridays

Package includes: Competitive salary, 25 days holiday (plus 8 bank holidays), life assurance cover, subsidised private medical insurance, pension scheme.

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 $17 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.

This role is based at our Microbiology (MBD) site in Basingstoke. Our microbiology products are used to diagnose infectious disease and identify appropriate antibiotic treatment, confirm that food and beverage products are safe to eat and drink, and ensure that pharmaceutical products are sterile. Our broad range products include prepared and dehydrated culture media, rapid and direct specimen tests, and flu testing kits.

If your throat is swabbed to check for strep throat, microbiology makes the ready-plated culture media on which the swab is tested. Microbiology solutions also include products used for testing urinary tract infection in patients, and for identifying bacteria such as E.coli and Salmonella in food and potentially harmful microorganisms in water.

Key Responsibilities:

  • Prepare the annual audit plans and carry out internal and external quality audits to ensure compliance with ISO 13485, ISO 9001, FDA 21 CFR 820 and the European IVD Directive.
  • To organize and host customer audits.
  • To ensure that product quality is maintained throughout the manufacturing process by quality audit / assessment and implementation of recommended quality improvements.
  • To ensure that supplier quality is maintained through quality assessment and implementation of recommended quality improvements.
  • To investigate Quality Notifications (Customer complaints).
  • To load product formulations and SOPs onto SAP as and when required.
  • Training Co-ordinator for MasterControl – Electronic Document Management system.
  • Manage the data for MasterControl system.
  • Provide Quality input to product-related investigations, deviations, change controls, validation protocols, validation reports, and SOPs.
  • Enable collaborative relationships between internal stakeholder departments and Quality with the overall focus of improving customer satisfaction.
  • Work closely with Operations, R & D, Purchasing and Engineering to improve quality while reducing material scrap and costs.
  • Assure that Basingstoke site standards comply with division policies, national and international codes, and applicable safety requirements.
Minimum Requirements/Qualifications:
  • Bachelor’s degree required in science discipline or related field.
  • Proven experience in QA.
  • Experience in auditing practices and principles; formal auditor training desirable.
  • Demonstrated working knowledge of compliance, quality and scientific principles.
  • Must be a self-starter who can take general concepts and direction and produce desirable results.
  • Willingness to undertake on the job training in all areas of the supply chain.
  • Ability to prioritize multiple tasks functions effectively in a global, multi-site organization.
  • Strong working knowledge of quality related tools, such as structured problem solving, FMEA (Failure Mode and Effects Analysis), SPC (Statistical Process Control), DOE (Design of Experiments) and Six Sigma/PPI.
  • Experience with lean manufacturing practices.
  • Knowledge of qualification / validation (process, sterilization, cleaning, software) requirements.
  • Perform independently without continual direction and exercise considerable latitude in determining technical objectives and solutions to complex problems.
  • Willingness to travel within the UK and abroad to undertake quality audits and assessments.
  • Current clean driving record.
  • May be required to perform other related duties as required and / or assigned.
  • Experience in supervising or leading small teams to a successful outcome is desired.
Non-Negotiable Hiring Criteria:
  • Medical device, GMP, EU Regulation or ISO 13485 background.
  • Significant experience with administering quality systems such as change control, CAPA, training, etc.
  • Strong working knowledge of various computer software, such as SAP, as well as Microsoft Word, Excel and PowerPoint.
  • Excellent oral and written communication skills.
  • Strong leadership skills with the ability to challenge, influence, and build consensus.
  • Ability to work both independently and as a team member.
  • Strong quality background and problem analysis and decision-making skills.

At Thermo Fisher Scientific, each one of our 50,000 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. Apply today http://jobs.thermofisher.com


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