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Thermo Fisher Scientific

Makes lab instruments, reagents and supplies

Team Lead – Quality Control Microbiology

Regulatory & Quality (Life Sciences)Confirmed live in the last 24 hours
Full-timePlainville, MA, USA

About the Job

Requirements

  • An advanced degree with no prior experience, or a bachelor's degree plus two years of experience in pharmaceutical manufacturing or a contract development and manufacturing organization.
  • Experience in bioburden and endotoxin testing for pharmaceuticals.
  • Experience in environmental monitoring in ISO 8, ISO 7, and ISO 5 environments.
  • Expert knowledge of Good Manufacturing Practice regulations, International Council for Harmonisation guidelines, and pharmacopeia standards.
  • Strong technical proficiency with analytical instrumentation and testing methods.
  • Experience with laboratory information management systems and quality documentation.
  • Demonstrated success implementing process improvements and troubleshooting investigations.
  • Experience managing laboratory equipment, calibration, and maintenance programs.
  • Knowledge of environmental monitoring and contamination control.
  • Ability to work various schedules to support 24/7 operations.
  • Proficiency with Microsoft Office and statistical analysis tools.
  • English proficiency.
  • Ability to pass a comprehensive background check, including drug screening.
  • Legally authorized to work in the United States now and in the future without sponsorship.

Responsibilities

  • Lead a quality control team to ensure product quality and regulatory compliance.
  • Contribute to analytical testing and quality control operations.
  • Work with cross-functional teams to implement quality improvements, troubleshoot technical issues, and maintain Good Manufacturing Practice standards.
  • Support and develop team members while ensuring efficient laboratory operations, timely completion of testing, and meticulous documentation of results.
  • Interface with clients and regulatory bodies as a subject matter expert.
  • Manage laboratory equipment and calibration and maintenance programs.

Desired Qualifications

  • Industry certifications in Good Manufacturing Practice and Good Documentation Practice.
  • One to two years of demonstrated leadership experience managing technical teams.
  • Additional languages.

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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