Quality Assurance Document Control Specialist III (Biotech)
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.
As an Quality Assurance Document Control Specialist III at Lonza AG, you will chip in to our document control processes. You will join a dedicated team working on life sciences solutions and Lonza's growth! Located in New Hampshire, USA, you will work in a collaborative environment.
Key responsibilities:
Issue Batch Production Records to Manufacturing, ensuring accuracy and timeliness.
Issue In Process Labels to Manufacturing, strictly adhering to quality standards.
Apply SAP, databases, and spreadsheets for quality tracking, ensuring data integrity.
File records and archive documents systematically to maintain an organized document management system.
Support audits and inspections by providing necessary documentation and insights.
Assist with the administration of the Electronic Document Management System (DMS) and guide employees on its usage.
Format documents and draft procedures to ensure clarity and compliance.
Support on-the-floor Batch Record review, ensuring records are complete and accurate.
Collaborate with the QA Compliance team to successfully implement day-to-day activities effectively.
Key requirements:
Associate's degree or 2 years of experience in a related field.
Proficiency in computer software, including Microsoft Office. Experience with ERP and EDMS systems is advantageous.
Basic knowledge of GMP and Part 11 compliance.
0-4 years of experience in a related area, demonstrating a proven ability to compete in a rigorous quality environment.
Outstanding attention to detail and a determined approach to achieving outstanding results.
Join us at Lonza AG and be part of a team that is dedicated to making a meaningful difference through high-quality life sciences solutions.
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.
