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.

Lonza Houston’s Cell and Gene Therapy Facility is the largest and most advanced in the world. As our facility continues to grow, we are looking for dedicated and hardworking professionals to join our team. We have an outstanding opportunity in our Quality Assurance (QA) group for a Batch Release Specialist. This role is crucial for ensuring the smooth approval of all materials produced at the LHI site, except raw materials and buffers. The Batch Release Specialist will represent the QA department in internal and external meetings regarding batch release, maintaining our high-quality standards.

Key responsibilities:

• Serve as a technical leader for the implementation of Quality Systems at the LHI site, mentoring junior staff members.




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




• Coordinate the disposition of batches produced at the LHI site and maintain a comprehensive batch release tracking system.




• Collaborate with other teams to successfully implement batch records, deviations, change controls, and Environmental Monitoring reports.




• Identify and implement changes to current Quality Systems to improve compliance, effectiveness, and efficiency.




• Maintain quality systems and cGMP alignment by ensuring all team members strictly follow processes, procedures, and instructions.




• Support investigations into quality system breakdowns using problem-solving tools as owner or QA approver.




• Coordinate the execution and closure of corrective actions and change controls as owner or QA approver.




• Partner with the Inspection Management group to identify and address compliance gaps during internal and external site audits.




• Track quality records reviews and dispositions, participate in internal/external audits, and ensure overall cGMP compliance.

Key requirements:

• Bachelor’s Degree or equivalent experience in a Life Sciences field.




• Proven track record in batch disposition activities within a cGMP environment, with commercial GMP experience preferred.




• Knowledge of GMP compliance, including 21CFR210, 211, 820, PICS Guide to Good Manufacturing Practices, EU Guidelines for Medicinal Products, FDA Mentorship on Aseptic Processing, and Part 11 compliance preferred.




• Proficiency with Root Cause Analysis Tools, Risk Management, Technical Writing, Microsoft Office applications, TrackWise, DMS, SAP, and LIMS systems.




• Ability to work efficiently in a fast-paced environment and effectively prioritize tasks.




• Great teammate with a strong focus on safety, quality, and timelines.




• Strict compliance with company and site safety policies.

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.