QA Specialist I – Quality Systems

United States, Hayward (California)

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.

QA Specialist , under direct supervision, is responsible for supporting the Quality Systems department to ensure compliance in operational areas. Through their fundamental knowledge, assists the site by providing Quality Assurance support for operational areas involved in the execution of GMP-related activities.

Key responsibilities:

  • Perform quality review of GMP documentation in support of routine engineering/validation activities.
  • Edit GMP documents and route using the Document Management System.  
  • Assist with site quality metrics.
  • Support site with tracking of quality records - Trackwise system
  • Data entry of employee training records using the Learning Management System.
  • Assist employees in the use of the LMS.
  • Revise or review standard operating procedures and submit procedural changes as needed to meet local, Global and Regulatory requirements.
  • Perform other duties as assigned.   
  • Investigate deviations and write nonconformance investigation reports
  • Working knowledge of applicable CTP/SOPs, GMP, FDA Regulations, application of cGMP/GDPs.

Every day, Lonza’s products and services have a positive impact on millions of people. For us, this not only a great privilege, but also a great responsibility.  How we achieve our business results is just as important as the achievement 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: R30371
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