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.
Join Lonza AG as we continue to transform the life sciences industry! We are seeking a dedicated Quality Assurance Specialist IV, Quality Management Systems, to join our ambitious team in Houston, TX. In this vital manufacturing role, you will help us maintain our world-class standards by ensuring flawless quality management systems. Your contributions will help us compete at the highest levels and successfully implement our strategic goals.
Key responsibilities:
Act as TrackWise system administrator and provide site trainings for various record/module types, including deviation, investigation, CAPA, change control, and audit.
Coordinate electronic system applications that impact QMS, like SAP (SAP QA role approvals) and TrackWise user administration.
Support the execution of the change control, deviation, CAPA, and efficiency check systems.
Train and support site subject matter experts (SMEs) in completing change control, deviation, CAPA, and efficiency checks.
Coordinate the site's change control, deviation, CAPA, and efficiency check programs.
Serve as an SME in compliant change control, deviation, CAPA, and efficiency checks.
Function as a TrackWise SME related to change control, deviation, CAPA, and efficiency check modules.
Support and host change controls review board, deviation review board, and CAPA review board.
Act as an SME related to change control, deviation, CAPA, and efficiency check systems in customer and Health Authority inspections.
Provide critical metrics for change control, deviation, CAPA, and efficiency check systems.
Key requirements:
Bachelor’s Degree in Life Sciences, Engineering, Quality Management, or related field.
Advanced experience (5-10 years) in biopharmaceutical manufacturing experience and/or quality operations plus quality systems working in a GMP environment.
Solid experience with change control, deviations, and CAPAs.
Experience with TrackWise.
Familiarity with Health Authority Regulations (US FDA, EMA, MHRA, etc.).
Experience in an aseptic manufacturing environment.
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.