Agile Quality Analyst

6 days ago

Kingston, United States Lonza Full time
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Today, Lonza is one of the worlds largest healthcare manufacturing organizations operating across five continents.

Join Lonza AG as an Associate Director, QA Sterility Assurance - LSA, and become part of an outstanding team dedicated to hardworking and flawless execution in life sciences. This outstanding opportunity allows you to craft the sterility assurance program within our ambitious and rapidly growing healthcare manufacturing organization. Be at the forefront of innovation and quality as we continue our world-class operations across five continents.

Provide QA oversight of Aseptic Processing Program, Environmental Monitoring, and Microbial Control Policies for Cell Therapy and Viral Therapy Operations.Independently review and approve policies, procedures, and completed media fill/APS documentation.Coordinate Environmental Monitoring sample plans, cleanroom qualifications, and manage environmental monitoring excursions, deviations, and sterility failures.Conduct reviews of sterile filter validations and integrity testing procedures.Collaborate closely with Cell and Viral Therapy Operations Management, as well as QC and QA leadership, to ensure strict adherence to sterility assurance standards.Maintain sterility assurance for aseptically manufactured sterile drug products and viral vector products, ensuring they meet the highest quality and regulatory standards.

  • Bachelor's Degree in life sciences field.
  • 7-10 years of experience in QA oversight within a similar role.
  • Excellent communication and collaboration skills to interact with cross-functional teams and ensure seamless operations.
  • Dedication to upholding world-class standards in sterility assurance and quality control.

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