QA Specialist

United States, Portsmouth (New Hampshire)

Today, Lonza is one of the world’s 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.

Key responsibilities:

• 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.

Key requirements:

• Bachelor's Degree in life sciences field.
• 7-10 years of experience in QA oversight within a similar role.
• Proven ability to work independently with minimal direction.
• Strong analytical skills to determine and successfully implement effective sterility assurance strategies.
• 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.

This is an outstanding opportunity to join a team dedicated to making a significant difference in the life sciences industry. At Lonza, your contributions will help us continue to deliver high-quality healthcare solutions that have a positive impact on millions of people globally. Apply today and take the next step in your career with a company that values innovation, integrity, and excellence.
Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.

People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.

Lonza is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a qualified individual with disability, protected veteran status, or any other characteristic protected by law.

Reference: R63587