Documentation Supervisor

United States, Hayward (California)

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.

The Documentation Supervisor supporting the Hayward facility is responsible for the follow activities for the site: administration of the electronic documentation system, facility records management program, documentation issuance, labeling management, and management the on- and off-site archive.  If applicable, supervise 1 or more Document Control Specialists.

Key Responsibilities:

  • Administration of the Document Management System. Initiate workflows, edit documents, assist and educate other employees on use of the system, manage documents within the workflows, etc.
  • Aid in the development of training curricula and design training materials. Roll out training to the site on any changes to system.
  • Respond to and resolve user issues with the Document Management System, including troubleshooting in coordination with IT personnel as a Subject Matter Expert.
  • Responsible for managing the archived records including completed batch records, component specifications, and other quality documentation for the site. 
  • Manage accounts for vendors performing services for Hayward Document Control.  Support requests for site records and information needs.
  • Issue production batch records, lab notebooks, and labeling as requested by the manufacturing and laboratory departments.
  • Effectively work with local and global teams to provide technical support/expertise/leadership in overseeing the records management program. 
  • Provide leadership/guidance and coaching to personnel, if applicable.
  • Design and implement Access Databases and Excel spreadsheets to collect various types of data for Document Control.
  • Support Change Control system. Act as change owner as required.
  • Open deviation events as required in the deviation management systems.
  • Take ownership of internal and external quality commitments and drive to on-time closure.

Key requirements:

  • Bachelor’s degree -Preferred area of study: Records Management, Information Governance, e-Discovery (EDRM) Information Management (IM) or similar area of study.
  • Advanced years of experience with document management systems/Quality Systems and management of GMP documentation such as Standard Operating Procedures. 
  • A functional understanding of FDA & EMA regulations and Quality Systems is required.
  • This position demonstrates effectiveness in task completion, decision-making, empowerment of others, exception management, training, problem solving and team leadership.
  • Data/Document configuration management expertise.
  • Ability to create and facilitate training.
  • Page layout fundamentals and in-depth knowledge of graphics standard for GMP documentation and labeling.
  • Working knowledge of FDA Regulations, particularly regulations relative to Records Management.

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: R38244