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Thermo Fisher Scientific

Makes lab instruments, reagents and supplies

Quality Assurance Specialist

Regulatory & Quality (Life Sciences)Confirmed live in the last 24 hours
Full-timeVilnius, Vilnius City Municipality, LithuaniaIn-person

About the Job

Requirements

  • A higher-education qualification in chemistry, biochemistry, biology, molecular biology, biotechnology, bioengineering, or another natural-sciences field is required.
  • Work experience in quality assurance or quality control is required.
  • Good English language skills are required.
  • Good computer skills, including MS Office, are required.
  • Analytical thinking and the ability to interpret research results are required.
  • The ability to analyze nonconformities, identify their causes, and solve problems is required.
  • Carefulness, accountability, and attention to detail are required.
  • The ability to work independently and collaborate effectively with a team is required.

Responsibilities

  • Prepare, review, and update quality assurance documentation in accordance with ISO 13485 and Good Manufacturing Practice requirements.
  • Participate in quality assurance processes, including handling deviations, nonconformities, and customer complaints, and managing risks.
  • Check and approve manufacturing, testing, and environmental monitoring protocols, and prepare documentation required for product release.
  • Issue batch manufacturing and analysis protocols and assess readiness for batch production.
  • Coordinate initial and periodic employee training in accordance with Good Manufacturing Practice requirements.

Desired Qualifications

  • Knowledge of ISO 13485 and Good Manufacturing Practice requirements, including practical experience applying them.
  • Knowledge of aseptic manufacturing principles.
  • Knowledge of analytical and microbiological quality control testing.

About the Company

Thermo Fisher Scientific

Makes lab instruments, reagents and supplies

Thermo Fisher Scientific makes and sells the instruments, chemicals, consumables and lab services that drug companies, hospitals, universities and industrial labs use for research, testing and production. Its products cover work from gene sequencing and protein analysis to diagnostic tests and lab freezers, and its distribution arm ships supplies to labs worldwide. Drug developers also hire it to run clinical trials and to manufacture medicines under contract. It earns money from consumables that labs buy again and again, along with instrument sales, service contracts and outsourcing fees. The company traces its roots to Thermo Electron, founded in 1956, which merged with Fisher Scientific in 2006, and it is based in Waltham, Massachusetts.

Company size
10,001+
Company stage
IPO
Headquarters
Waltham, MA
Founded
1956

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