Lonza Group Ltd.
Associate Director, QA Sterility Assurance - LSA
Lonza Group Ltd., Portsmouth, New Hampshire, United States, 00215
Associate Director, QA Sterility Assurance - LSA
Today, Lonza is one of the world’s largest healthcare manufacturing organizations operating across five continents.Responsibilities:Responsible for QA oversight of Aseptic Processing Program, Environmental Monitoring, and Microbial Control Policies for the Cell Therapy and/or Viral Therapy Operations.Work independently with little direction to review policies and procedures and related completed media fill/APS documentation, Environmental Monitoring sample plans, cleanroom qualifications, environmental monitoring excursions, deviations, and sterility failures.Review of sterile filter validations, integrity testing, and procedures is also required.Interact with Cell and Viral Therapy Operations Management, QC, and QA leadership.Maintain sterility assurance of Aseptically manufactured sterile drug products and viral vector products.Requirements:Bachelor's Degree in a life sciences field.7-10 years of experience.
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Today, Lonza is one of the world’s largest healthcare manufacturing organizations operating across five continents.Responsibilities:Responsible for QA oversight of Aseptic Processing Program, Environmental Monitoring, and Microbial Control Policies for the Cell Therapy and/or Viral Therapy Operations.Work independently with little direction to review policies and procedures and related completed media fill/APS documentation, Environmental Monitoring sample plans, cleanroom qualifications, environmental monitoring excursions, deviations, and sterility failures.Review of sterile filter validations, integrity testing, and procedures is also required.Interact with Cell and Viral Therapy Operations Management, QC, and QA leadership.Maintain sterility assurance of Aseptically manufactured sterile drug products and viral vector products.Requirements:Bachelor's Degree in a life sciences field.7-10 years of experience.
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