QA Specialist IV (Biotech)

Today, Lonza is a global leader in life sciences operating across three 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.

At Lonza AG, we are proud to be leading the way in the life sciences industry, with our innovative solutions making a significant global impact. Our Cell and Gene Therapy Facility in Houston, TX, is the largest of its kind, and we are rapidly growing our team. This is an outstanding opportunity for a dedicated professional to join our Quality Assurance group as a QA Specialist IV.

Key responsibilities:

• Perform QA on the floor reviews for the Quality Control (QC) laboratory at the site.

• Review and approve completed QC documentation, including test records, lab investigations, system suitability, stability reports, assay qualification protocols/summary reports, and environmental monitoring.

• Interact directly with internal and external customers to acquire necessary documentation for processing.

• Manage deviations and change controls as owner or QA approver in the Trackwise system.

• Write, revise, and approve master documents, including forms, guidelines, and specifications.

• Apply GMP knowledge to ensure QC processes align with effective procedures and regulatory requirements.

• Maintain compliance with all required training and assist in training fellow analysts.

Key requirements:

• Bachelor's degree in life sciences.

• 5-10 years of experience in a QA role, with knowledge of aseptic techniques, GDP/GMP requirements, material release, and investigation skills.

• In-depth understanding of cGMP principles with the ability to identify breaches and suggest corrective actions.

• Proficient in proposing ideas during problem solving, root cause analysis, and process improvement events.

• Reliable teammate capable of effectively representing the department in meetings and on project teams.

• Leadership skills, offering mentorship to co-workers regarding compliance and personal interactions.

• Experience with SAP, Trackwise, and LIMS is a plus.

Be part of a team striving to implement top solutions and make a positive impact.

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.