Description

You will manage product disposition and lot closure for commercial and clinical products at our El Segundo site.

Responsibilities

• Perform product disposition and lot closure, ensuring all batch-related documentation is reviewed and issues are resolved prior to release.
• Provide QA oversight for deviations, CAPAs, and change records to ensure they are initiated, investigated, and resolved within established timelines.
• Review batch-related shipment documentation to verify product remained in control during transit.
• Support investigations and batch record reviews while ensuring manufacturing process control measures are followed.
• Maintain disposition metrics for management review and generate necessary procedures, forms, and documentation.

Required Skills

• Master’s Degree and 5+ years of experience in a GMP environment, OR Bachelor’s Degree and 7+ years of experience, OR High School Degree and 11+ years of experience.
• Direct experience with product disposition and lot closure in a GMP environment.
• Proven ability to manage deviations, CAPAs, and change records.
• Experience reviewing batch records and shipment documentation.
• Ability to interpret and apply regulatory guidance in ambiguous situations.
• Strong analytical and written communication skills.
• Ability to work onsite during day shifts, including weekends.

Preferred Skills

• Bachelor’s degree in biological sciences or a related field.
• 7+ years of progressive experience in pharmaceutical, biotech, or biologics operations.
• Working knowledge of U.S. and EU GMP standards.

Key Skills

Education

Master’s degree