Quality Assurance Document Control Supervisor

United States, Walkersville (Maryland)

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.

Document Control Supervisor will manage the department in compliance with current Good Manufacturing Practice (GMP) and ISO 9001 requirements. Includes supervision of staff, continuous improvement and control of documentation, records management and archiving policies and procedures.

Key responsibilities:

  • Administration of DMS change process for Lonza Bioscience Operations / Support Services, and site-wide administrative/technical procedures and forms.
  • Leads and supports the Issuance of Manufacturing Records, Controlled Logbooks, Standard Operating Procedures (SOPs) and Validations.
  • Leads and supports the Scanning and Archiving process of complete Quality Records.
  • Collaborates with other departments to define and harmonize effective, efficient business solutions.
  • Coordinates/Delegates projects for the Document Control Department.
  • Develops and manages direct reports.
  • Writes and revises procedures, as needed, to ensure alignment with defined Quality objectives.
  • Works with document owners to ensure accuracy and compliance of documents in DMS through on-time completion of document reviews.
  • Serves as lead for investigations related to Document Control.
  • Is knowledgeable and complies with all pertinent safety policies, rules and regulations.

Key requirements:

  • Bachelor’s Degree in Life Sciences or Related Field
  • cGMP environment and related Quality Assurance Field
  • Strong working knowledge and expertise in electronic document management systems
  • Demonstrated Project Management skills
  • Understanding of product lifecycle documentation systems
  • Strong understanding of current regulations, including 21CFRs, GxP, ICH, ISO, etc.

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: R22692