Hiring: Batch Release Specialist, Quality Assurance Operations Company: Lonza Location: Houston, TX Job Posted Time: 2026-09-12 14:48:06 Target Skills & Keywords : Microsoft Office, Project Management, Risk Management, Root Cause Analysis, SAP About the job Experience: •7-10 years) in batch disposition activities within a cGMP environment. •10 years) in batch disposition activities within a cGMP environment. Required Skills: •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. Qualifications: •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. •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. Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!