Batch Release Specialist, Quality Assurance Operations

Lonza Group Ltd.; Houston (TX); On-site; USD 110,000 - 150,000; Full time

Job summary

Lonza Group Ltd. in Houston, TX seeks an experienced professional to oversee batch disposition in a cGMP environment, ensuring timely release of manufactured batches and coordination with QA and project teams. You will mentor junior staff and help drive continuous quality improvements.

Requires a Bachelor's in life sciences and 7–10 years' GMP batch disposition experience, plus proficiency with TrackWise, SAP, LIMS, DMS, and strong technical writing skills.

Qualifications

• Bachelor’s degree in life sciences (biotechnology, biochemistry, biology, chemistry, or related field).
• 7–10 years of batch disposition experience in a cGMP environment.
• Direct GMP experience in the pharmaceutical industry.
• Proficiency with TrackWise, DMS, SAP, LIMS, and MS Office.
• Strong focus on safety, quality, and timely delivery.

Responsibilities

• Disposition of batches manufactured at the LHI site, including maintaining a batch release tracking system.
• Collaborating with other teams to ensure all necessary tasks for batch disposition are finished, including performed batch records, deviations, change controls, and Environmental Monitoring reports.
• Mentoring junior staff members in helping to address feedback on batch records and test record forms.
• Collaborating with the Project Management and QA leadership teams to implement changes to the batch release process, improving compliance, effectiveness, and efficiency.
• Identifying and implementing improvements in the Quality Systems to boost compliance and efficiency.
• Maintaining quality systems and cGMP compliance by ensuring team adherence to processes, procedures, and instructions.
• Promoting and ensuring job safety, attending required health and safety training, and reporting any actual or potential accidents and injuries promptly.

Skills

Root Cause Analysis

Risk Management

Technical Writing

Microsoft Office

TrackWise

DMS

SAP

LIMS

Education

Bachelor's degree in life sciences

Job description

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:

• Disposition of batches manufactured at the LHI site, including maintaining a batch release tracking system.
• Collaborating with other teams to ensure all necessary tasks for batch disposition are finished, including performed batch records, deviations, change controls, and Environmental Monitoring reports.
• Mentoring junior staff members in helping to address feedback on batch records and test record forms.
• Collaborating with the Project Management and QA leadership teams to implement changes to the batch release process, improving compliance, effectiveness, and efficiency.
• Identifying and implementing improvements in the Quality Systems to boost compliance and efficiency.
• Maintaining quality systems and cGMP compliance by ensuring team adherence to processes, procedures, and instructions.
• Promoting and ensuring job safety, attending required health and safety training, and reporting any actual or potential accidents and injuries promptly.

Key requirements:

• Bachelor’s degree in life sciences (biotechnology, biochemistry, biology, chemistry, engineering) or related field.
• Proven track record (7-10 years) in batch disposition activities within a cGMP environment.
• Direct GMP experience within the pharmaceutical industry.
• Proficiency in Root Cause Analysis Tools, Risk Management, Technical Writing, Microsoft Office applications, TrackWise, DMS, SAP, and LIMS systems preferred.
• Strong contributor who prioritizes safety, quality, and timelines.
• Knowledge of GMP compliance, including 21CFR210, 211, 820, and the PICS Guide to Good Manufacturing Practices, ICH Q7, 13485, and Part 11 compliance preferred.

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.