Quality Assurance Specialist

4 weeks ago


Allendale, Michigan, United States Actalent Full time

Job Title: Quality Assurance Specialist

Job Description:

As a Quality Assurance Specialist at Actalent, you will be responsible for ensuring compliance with cGMP and cGTP regulations in pre-clinical, clinical, and commercial manufacturing. Your duties will include performing raw material inspections, issuing and maintaining cGMP and cGTP documentation, and conducting line clearance prior to manufacturing operations.

Responsibilities:

  • Perform raw material inspections and raw material release according to SOPs and in compliance with all regulatory standards.
  • Issue and maintain all cGMP and cGTP documentation, including logbooks and training binders.
  • Conduct line clearance prior to manufacturing operations.
  • Ensure compliance with all FDA and Worldwide Quality & Compliance regulations as applicable to the job function.

Requirements:

  • Quality Assurance
  • cGMP and cGTP documentation
  • Raw material inspections
  • Issuance of batch records
  • Accessioning of incoming apheresis
  • Line clearance
  • Compliance with FDA and Worldwide Quality & Compliance regulations
  • Document management
  • Review of QC data
  • Material releases
  • Final product releases

Work Environment:

This is a fully on-site position in a manufacturing facility. You must be able to work in a team-oriented environment and with clients. You may be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluids. You must utilize proper personal protective equipment (PPE) when handling all human specimens, gases, corrosive chemicals, and liquid nitrogen.



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