Documentation/Quality Systems Specialist

United States, Portsmouth (New Hampshire)

This Documentation/Quality Systems Specialist is a role in the Logistics area that is responsible for the authoring and revising of cGMP documentation as well as initiation of Quality System (Trackwise) records, to include Deviations, Change Controls, and Corrective/Preventative Actions. 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.

·       Process GMP documentation – to include authoring, editing, and reviewing documentation within the Lonza Documentum system

·       Collaborate with Logistics personnel and solicit input for inclusion in GMP documents

·       Initiate Quality events in the Lonza Trackwise system, to include deviations, CAPA, and Change Controls as required

·       Lead investigations into Quality events, to include deviation investigations to ensure that quality standards have been attained

·       Meet all required deliverables for CAPA and Change Control tasks

·       Support Quality record closure for records assigned to other Logistics employees as necessary

·       May be required to be trained on and perform various support functions such as log book reviews and other Supervisor related tasks.

Perform other duties as assigned

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.

Lonza’s Portsmouth, NH site has had a lot of growth over the past few years, including building a fully automated manufacturing suite, and manufacturing mRNA technology for the covid19 vaccine. The site is continuing it’s growth, and looking to build teams to support upcoming expansions.

This Documentation/Quality Systems Specialist is a role in the Logistics area that is responsible for the authoring and revising of cGMP documentation as well as initiation of Quality System (Trackwise) records, to include Deviations, Change Controls, and Corrective/Preventative Actions. 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.

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: R38367
Similar Jobs