Batch Release Specialist, Quality Assurance Operations

Lonza is a global leader in life sciences worldwide. This role focuses on batch disposition at the LHI site.

• Disposition of batches manufactured at the LHI site, including maintaining a batch release tracking system.
• Collaborate with other teams to ensure all necessary tasks for batch disposition are completed, including batch records, deviations, change controls, and Environmental Monitoring reports.
• Mentor junior staff members to address feedback on batch records and test record forms.
• Work with Project Management and QA leadership to implement changes to the batch release process, improving compliance, effectiveness, and efficiency.
• Identify and implement improvements in the Quality Systems to boost compliance and efficiency.
• Maintain quality systems and cGMP compliance by ensuring adherence to processes, procedures, and instructions.
• Promote and ensure job safety, attend required health and safety training, and report any actual or potential accidents and injuries promptly.

• Bachelor’s degree in life sciences (biotechnology, biochemistry, biology, chemistry, engineering) or related field.
• 7–10 years of proven experience in batch disposition activities within a cGMP environment.
• Direct GMP experience within the pharmaceutical industry.
• Proficiency with Root Cause Analysis tools, Risk Management, Technical Writing, Microsoft Office applications, Track Wise, DMS, SAP, and LIMS systems.
• Strong contributor who prioritizes safety, quality, and timelines.
• Knowledge of GMP compliance, including 21
  
  CFR
  210, 211, 820, and the PICS Guide to Good Manufacturing Practices, ICH Q7, 13485, and Part 11 compliance preferred.

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.