QA Specialist II-Operations OTF at Lonza Inc. in Portsmouth, New Hampshire

Job Description:

Today, Lonza is a global leader in life sciences operating across five continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of.

Join Lonza AG as a QA Specialist II-Operations OTF and be part of a team that is committed to delivering world-class quality assurance in New Hampshire, USA! This role is pivotal in ensuring that our operations maintain strict compliance with GMP standards, contributing to our mission of improving lives globally. As we continue to grow ambitiously, your expertise will help us achieve flawless execution in our daily tasks.

Key responsibilities:

• Perform daily rotations through GMP operational areas to review documentation and observe work habits.


• Provide mentoring and feedback on GMP and documentation behaviors, partnering closely with Manufacturing Management.


• Offer GMP mentorship to Manufacturing for both routine and non-routine issues.


• Elevate complex issues to senior staff and management for resolution.


• Respond to QA Hotline calls supporting GMP operations, ensuring timely and effective responses.


• Make independent decisions on simple GMP issues and consult senior staff for complex decision-making.


• Authorize placement and removal of Quality Tag Outs, and release equipment from Product Changeover.


• Apply Data Integrity principles in all tasks, strictly adhering to Lonza's DI policies, guidelines, and procedures.


• Represent QA in meetings or project teams, gaining insights from senior staff on decision-making processes.


• Perform other duties as assigned, contributing to the overall success of the QA team.

Key requirements:

• Proven experience in a GMP environment, with a strong understanding of quality assurance practices.


• Outstanding attention to detail and the ability to handle complex, time-sensitive assignments.


• Effective feedback provider with clear communication abilities.


• Ability to work collaboratively with diverse teams and independently when necessary.


• Demonstrated ability to successfully implement quality assurance measures and elevate issues appropriately.


• Familiarity with Data Integrity principles and dedication to maintaining high standards of compliance.

Become a part of Lonza AG and help us maintain our reputation for excellence in quality assurance. Your contributions will be integral to our continued success!

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.