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

Job Description:

Today, Lonza is a global leader in life sciences operating across three 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.

As a Quality Assurance Specialist 3 at Lonza AG, you will have a relevant role in ensuring the detailed execution of our Site operations! This position is uniquely crafted for those with a passion for excellence and a proven track record to support and improve quality standards. Join us in our daring journey towards ongoing growth and innovation in New Hampshire, USA!

Key responsibilities:

• Independently review and approve initial versions and revised documents such as SOPs, Work Instructions, eBR and Automation Documentation, Forms & Checklists, Scanned Documents, and other vital documentation within a Document Management System.




• Review and approve Validation/Qualification documents for electronic and/or paper formats. This includes Protocols & Summary Reports for Equipment/Instrumentation, Validation Maintenance, and related Computer and Analytical Systems.




• Review and approve non-DMS documents such as QA Monthly Preventative Maintenance, Engineering Preventative Maintenance documents, CMMS Forms, Instrumental Data Sheets, Functional Equivalent Memos, DMS Withdrawal Forms, Periodic Review Audit Trail, and various Facility Forms.




• Provide detailed observations and suggested edits/comments during document reviews, ensuring adherence to Lonza’s documentation review procedures.




• Ensure changes are supported appropriately and accurately reflected in the documents, closely following associated documentation revision and review procedures.




• Serve as a Subject Matter Expert (SME) for QA document review relevant to Equipment/Instrumentation, Validation Maintenance, and relevant Computer and Analytical Systems.




• Get along with internal customers, providing outstanding customer service and advancing issues as the need arises.




• Collaborate with other QA Specialists, QA PMs, and Management to identify, defend, and resolve quality issues.

Key requirements:

• Bachelor’s degree in Science or an equivalent combination of skills and experience.




• 5-10 years of experience in Pharmaceutical/Biotech/GMP environments.




• Outstanding ability to review and approve GMP documentation associated with Site operations, including Engineering, Facilities, Validation, MES or equivalent experience, and Quality Control.




• Strong analytical skills with a diligent approach to identifying and resolving quality issues.




• Proven track record to interact effectively with internal customers and provide outstanding customer service.




• Ability to strictly follow procedural documentation and advance concerns when vital.




• Excellent communication and collaboration skills to work successfully with cross-functional teams.

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.