Senior Batch Release & QA Operations Lead

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

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.