Job Description

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Office

Job Description

At Thermo Fisher Scientific Inc., the QA Lead, Biologics Sterility Assurance role offers an outstanding opportunity to ensure robust compliance of aseptic operations and sterility assurance systems across biologics manufacturing. This position is pivotal in driving excellence and flawless performance in contamination control, validation, and continuous improvement, strictly adhering to regulatory and corporate quality standards

Responsibilities:

Sterility Assurance System:

  • Lead and uphold the Sterility Assurance Program and Contamination Control Strategy (CCS) for facility, utilities, equipment, materials, personnel, and processes.
  • Lead risk assessments for aseptic processes, single-use systems, and critical int...

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