United States, Portsmouth (New Hampshire) Today, Lonza is a global leader in life sciences operating across three continents.' needs to be changed to 'Today, Lonza is one of the world's largest healthcare manufacturing organizations operating across five continents. Requirements
- Responsible for QA oversight of Aseptic Processing Program , Environmental Monitoring and Microbial Control Policies for the Cell Therapy and/or Viral Therapy Operations.
- Individual should be able to 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.
- The individual is expected to interact with Cell and Viral Therapy Operations Management, QC and QA leadership.
- Primary responsibility is to maintain sterility assurance of Aseptically manufactured sterile drug products and viral vector products.
Requirements
- Bachelors Degree in life sciences field
- 7-10 years of experience
Reference: R63587