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Today, Lonza is one of the world’s largest healthcare manufacturing organizations operating across five continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is dedicated 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 Documentation & System Specialist, this person continues to work with Logistics 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 will require the person to continue using TrackWise to maintain logistic related records. It will also now include the additional task of maintaining Change Request records and accompanying child records. These tasks will be performed with less supervision and more autonomy. Interacts with multiple departments within the site ensuring 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(DMS).
• 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 Request.
• Lead investigations into Quality events, to include deviation investigations to ensure that quality standards have been attained.
• Meet all required deliverables for CAPA actions and Change Request Tasks.
• Support Quality record closure for records assigned to other Logistics employees as necessary.
• May be required to be trained to perform various support functions and other Supervisor related tasks.
• May be required to perform outside of normal business hours to meet deadlines.
• Work individually on projects.
• Demonstrate leadership to less experienced members of the team.
• Mentor new team members.
• Leading by example – Taking initiative.
• Perform other duties as assigned.