Lonza
life sciences
BatchReleaseSpecialist,QualityAssuranceOperations
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optimal for Senior candidates.
“Batch Release Specialist, Quality Assurance Operations at Lonza. Skills: batch disposition, cGMP environment, Quality Systems. Disposition of batches manufactured at the LHI site. Maintain a batch release tracking system”
What You'll Achieve.
improving compliance, effectiveness, and efficiency; boost compliance and efficiency
Industry & Context.
attending required health and safety training, reporting any actual or potential accidents and injuries promptly
What They're Looking For.
Must Have
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
Nice to Have
Proficiency in Root Cause Analysis Tools, Risk Management, Technical Writing, Microsoft Office applications, TrackWise, DMS, SAP, and LIMS systems, Knowledge of GMP compliance, including 21CFR210, 211, 820, and the PICS Guide to Good Manufacturing Practices, ICH Q7, 13485, and Part 11 compliance
What You'll Do.
Disposition of batches manufactured at the LHI site
Maintain a batch release tracking system
Ensure all necessary tasks for batch disposition are finished
Implement changes to the batch release process
Identifying and implementing improvements in the Quality Systems
Maintaining quality systems and cGMP compliance
Promoting and ensuring job safety
How You'll Work.
Team & Collaboration
Collaborating with other teams to ensure all necessary tasks for batch disposition are finished; Collaborating with the Project Management and QA leadership teams to implement changes to the batch release process
Full 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
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