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 & Quality 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.

What you will do:

• 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.

What you will bring:

• High School or equivalent required. Bachelor's degree preferred.
• Excellent professional oral and written communication skills.
• High level of attention to detail at all times.
• High level of organization.
• Problem solving skills.
• Ability to re-prioritize activities as required by changes to daily activities.
• Ability to work in a fast-paced environment and react to any changes in daily scheduled activities.
• Able to work within a team, as well as drive team activities.
• Ability to work independently to complete all required activities.
• Ability to take charge of multiple projects at the same time.
• Ability to build a network of connections.

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.