Specialist III, Quality Assurance Documentation Control - LSA (Biotech)
Today, Lonza is a global leader in life sciences operating across five 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.
Are you an adventurous individual looking to join an outstanding team? Lonza AG is seeking a QA Specialist Level III-Document Control for our New Hampshire, USA location! This outstanding opportunity allows you to be responsible for the QA Document Control team, representing the QA department on project teams and ensuring that quality requirements are met. Join us and chip into our ongoing growth and success in the life sciences industry!
Key responsibilities:
Lead the QA Document Control team and represent to ensure quality requirements are closely met.
Handle document control tasks like workflows, printed copies, and change requests for SOPs and more in a digital system.
Assist with the administration of the Electronic Document Management System by initiating workflows, editing documents, and assisting employees with system usage.
Lead the document change requests process and issue documents as requested.
Cross-train with other Quality Systems members to serve as a backup for functions like deviations review board, change review board, and learning management system.
Support internal and external audits to resolve compliance.
Update and maintain document databases and Excel spreadsheets to collect data for the Document Control group.
Perform Quality Assurance review and approval of quality systems records including change controls, deviations/investigations, CAPAs, and controlled documents.
Key requirements:
Validated experience in document control and quality assurance within the life sciences industry.
Outstanding ability to handle workflows and document change requests in an electronic documentation management system.
Strong skills in initiating workflows, editing documents, and assisting others with system usage.
Competence in supporting and handling document change processes and issuing documents.
Ability to cross-train and serve as a backup for other quality system functions.
Experience in supporting internal/external audits.
Magnificent attention to detail and thorough Quality Assurance review and approval skills.
Ability to perform project-related tasks and other assigned duties optimally.
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.
