QA Specialist III (3rd Shift Sun-Thurs from 11pm-8am)

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.

Key responsibilities:

• Represent the QA department to ensure that quality requirements are rigorously met.

• Support manufacturing operations and all related support groups in manufacturing execution.

• Apply problem-solving tools for supporting investigations and implementing corrective actions and change controls as required.

• Review and approve GMP master documents and completed GMP documents from various departments like QC, manufacturing, and material management.

• Track quality records and ensure overall cGMP compliance through QA on the floor execution.

• Verify the company’s compliance with ISO/GMP quality system requirements and other regulatory mentorship.

• Perform QA walkthroughs and collaborate closely with manufacturing and support groups to resolve identified issues.

• Review Master Batch Records (MBR) and supporting documents to support batch disposition.

• Conduct the Quality Assurance review and approval of GMP documents and Quality systems records.

• Proven experience in QA/QC teams, including aseptic technique and GDP/GMP experience.

• Expertise in material release, investigation skills, in-depth GMP, SAP, root cause analysis, aseptic process simulations, and assay qualification protocols/summary reports.

• Bachelor’s degree in Life Sciences, Engineering, or a related field.

• Outstanding ability to resolve compliance with regulatory requirements and implement necessary actions.

• Ambitious and collaborative approach with a dedication to maintaining flawless quality standards.

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.