Senior Document Control Associate

United States, Walkersville (Maryland)

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 Walkersville is a Senior Document Control Associate. This individual will be responsible for performing duties in Document Control including administering the Document Management System in the role of QM1, issuance of documents as required by manufacturing, management of document change requests and approval workflows. Also responsible for filing and archiving quality documents. In the absence of the Documentation Supervisor, will act on their behalf.

Key responsibilities:

  • Administration of the Electronic Document Management System. Initiate workflows, edit documents, assist and educates other employees on use of the system, manage documents within workflows, etc.
  • Responds to and resolve user problems with the Electronic Document Management System, including trouble shooting in coordination with IT personnel as a Subject Matter Expert (SME).
  • Serves as point of contact for site and global team member (DMSCo) for implementation of new and/or upgraded EDMS.
  • Manages the organization of part history files, completed batch records and change requests including management of archived records.
  • Issue production documents as requested by manufacturing departments.
  • Designs and implements Access databases and Excel spreadsheets to collect various types of data for the Document Control group. Cross-trains other members of Document Control to serve as back up for other Document Control functions.
  • Responsible for managing the Off-Site Storage process for Archiving and Retrieving documentation.
  • Support audits and inspections as needed.
  • Interact and collaborate with colleagues on cross-functional work tasks.
  • Research and coordinate data information to prepare routine or periodic reports as requested by Supervisor.
  • Enters change requests into Change Control Databases; closing change requests as work is completed.
  • Actively contributes and supports global quality initiatives and strategies.
  • Prioritizes and manage a variety of projects simultaneously.
  • Other document projects as assigned by Quality Systems Management.

Key requirements:

  • Bachelor’s degree or a minimum of 5 years experience with word processing, electronic documentation systems, and manufacturing documentation such as  Standard Operating Procedures
  • Four to six years QA/QC experience preferred.
  • Computer software skills including Documentum, Microsoft Office, database and spreadsheet creation and maintenance; filing, organization, record keeping and planning skills; ability to manage multiple projects concurrently; time management skills.
  • GMP compliance and Part 11 compliance knowledge preferred.
  • Excellent written and oral communication skills to include accurate and legible documentation skills; listening skills.
  • Ability to work in a fast-paced environment; team oriented.
  • Independent and self-directed with a strong work ethic.
  • Project management skills.

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: R40163
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