Technical Document Specialist III

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 Technical Document Specialist III. This individual will be responsible for administration of an electronic documentation management system in the role of QM1 and DMSCO. Lead role in Document Control in organization, documentation issuance, filing, archiving and overall control of quality records.

Key responsibilities:

  • Administers the Electronic Document Management System (EDMS). Initiates workflows, edits documents, assists and educates other employees on use of the system, manages 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
  • 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.
  • Enters change requests into Change Control Databases; closing change requests as work is completed.
  • Assists with issuing production documents as requested by manufacturing departments
  • Actively contributes and supports global quality initiatives and strategies 
  • Prioritizes and manage a variety of projects simultaneously

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.
  • Written and oral communication to include accurate and legible documentation skills
  • Ability to work in a fast-paced environment; team oriented
  • Independent and self-directed with a strong work ethic.
  • Written and oral communication skills; listening skills
  • 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: R40161
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