Quality Assurance Specialist

2 days ago


Lexington, Kentucky, United States Genezen Full time
Job Overview

Genezen is seeking a talented Quality Assurance Specialist to join our team in Fishers, Indiana or Lexington, Massachusetts. With an estimated annual salary of $90,000 - $110,000, this role offers a competitive compensation package.

The successful candidate will be responsible for ensuring the quality and integrity of our products through various qualification activities. This includes performance qualification of equipment and utilities, environmental qualification, process transfer and scale-up, process validation, preparation of cGMP materials, and preparation of all relevant documentation to meet regulatory requirements.

Main Responsibilities:

  • Protocol generation, execution support, data analysis, report generation, and approval for various installation, operational, and performance qualification activities
  • Review and approve qualification documentation on behalf of the validation department
  • Ensure performance of all qualification activities is in accordance with local procedures, industry, and regulatory guidance
  • Support investigations into protocol nonconformances and site deviations
  • Serve as initiator and owner of validation-related change controls and corrective and preventative actions
  • Author standard operating procedures related to validation practices
  • Support the execution and generation of formal risk assessments
  • Support the generation and implementation of validation programs


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