Quality Assurance Document Associate

United States, Walkersville (Maryland)

Quality Assurance Document Control Associate

Today Lonza is a global leader in life sciences. We are more than 15,000 employees in more than 100 locations around the world. 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.

The Document Associate role is key for supporting daily documentation activities for all manufacturing areas & phases. Document Associate is mainly processing daily documents for the manufacturing area such as updates to Manufacturing instructions, Device History Records (DHRs), Document Issuance for manufacturing use, periodic review updates and other document updates required by Corrective and Preventative Actions (CAPAs), Deviations, and Change Controls .

Key responsibilities:

  • Assist with the entry and revision of part data in an ERP system.
  • Issue and File DHRs and other production documents.
  • Enter change requests into Change Control Databases; keep database updated as work on individual change requests progresses.
  • Maintenance of quality systems and cGMP compliance for the business by ensuring that all team members comply with processes, procedures and instructions for all activities in which the team participates.
  • Assist with the administration of the Electronic Document Management System. Assist other employees on use of the systems.
  • Utilize Microsoft Access databases and Excel spreadsheets inputting data used for quality tracking.
  • Other document projects as assigned by the department manager.

Key requirements:

  • Associate’s degree or a years of experience with word processing particularly of manufacturing documentation and Standard Operating Procedures.
  • Basic GMP and part 11 compliance knowledge nice to have not required
  • Computer software skills including, Microsoft Office.
  • Other ERP and EDMS experience helpful.
  • Filing, organization, record keeping and planning skills; ability to manage multiple projects concurrently; time management skills.
  • Written and oral communication skills, listening skills, independent and self-directed, team oriented

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: R24620