Documentation / Quality Systems Specialist

United States, Portsmouth (New Hampshire)

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.

In the role of document editor, this position works with Logistics employees and leadership to understand and implement documentation revisions as well as create new documents as required per the business needs of the department. For Quality Systems activities, this role interacts with multiple departments within the site to ensure that all quality and process requirements are met throughout the lifetime of the records.

Key responsibilities:

  • Revising of cGMP documentation as well as initiation of Quality System (Trackwise) records, to include Deviations, Change Controls, and Corrective/Preventative Actions.
  • Collaborate with Logistics personnel and solicit input for inclusion in GMP documents
  • Key Contributor to interviews and team development.

Key requirements:

  • HS diploma or AS in related science field
  • Significant years in industry or GMP background
  • Open to logistics
  • Knowledge with Trackwise-deviation, change controls, CAPA. 
  • Maintenance of project planning and due dates and overdue records.
  • Managing open records, workflow and delegation of documents through process.
  • Being involved in the planning for some of the docs, change controls.

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: R31925