Viral Vector Quality Assurance Specialist 2nd shift/ Tue - Sat

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, where your work makes an outstanding impact on global health! As a Viral Vector Quality Assurance Specialist, you'll be part of the largest Cell and Gene Therapy Facility in the world, right here in Houston, TX. This outstanding opportunity within our Quality Assurance group will see you supporting our ambitious growth, ensuring our manufacturing operations meet world-class quality standards.

Hours are 3:00 PM - Midnight CST, Tues-Sat, with a shift differential pay.

Key responsibilities:

• Support investigations using problem-solving tools as owner or QA approver.

• Complete and close corrective actions and change controls as the owner or QA approver.

• Review and QA approve GMP master documents and completed GMP documents from QC, manufacturing, material management, FE, and other support departments.

• Perform in-house buffer and media release.

• Generate, inspect, and release labels.

• Track quality records and ensure overall cGMP compliance.

• Perform QA review and approval of GMP documents including master documents, completed documents, and quality systems records such as change controls, deviations/investigations, CAPAs, and controlled documents.

• Perform QA walkthroughs and collaborate closely with manufacturing and support groups to resolve any issues identified, including quality and safety items.

• Review and approve GMP documentation generated due to manufacturing activities (batch records, forms, logbooks, work orders, etc.).

Key requirements:

• Bachelor’s degree in life sciences or an Associate's Degree with equivalent work experience.

• Experience in a direct GMP setting with QA within the pharmaceutical industry.

• GMP compliance knowledge, including 21CFR210, 211, 820 and the PICS Guide to Good Manufacturing Practices Part 1 and 2, or the EU Guidelines to Good Manufacturing Practice Medicinal Products for Human and Veterinary Use, including Annex 1.; ICH Q7, 13485 and Part 11 compliance knowledge preferred.

• Basic computer skills

• Very positive attitude and trainable

• Must be willing to work in a clean room 

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.