Senior Quality Assurance Clearance Associate
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.
Senior Quality Assurance Clearance Associate will lead the department in compliance with Good Manufacturing Practices (GMP) and Federal Regulations.
- Reviews completed Device History Records (DHR) /Master Batch Records for completeness and accuracy prior to product release.
- Releases/clears products in electronic inventory system.
- Interacts with other departments to coordinate the completion of necessary corrections to the DHR and related documents.
- Performs other independent non product clearance activities as assigned by the department manager (ie Trackwise activities, internal audits, Departmental Training Coordinator, and special projects).
- Review and approve deviations/investigations /CAPA/OOS
- 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.
- Bachelor’s degree in life sciences required
- GMP and part 11 compliance Knowledge
- 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.