Description

You will manage product disposition and lot closure for both commercial and clinical products.

Responsibilities

• Perform product disposition and lot closure, including reviewing batch-related documentation and shipment records to ensure control.
• Provide QA oversight for deviations, CAPAs, and change records to ensure they are initiated, investigated, and resolved within established timelines.
• Support investigations and batch record reviews while ensuring process control measures are followed during product manufacturing.
• Maintain metrics related to product disposition for Management Review and generate necessary data reports.
• Generate and update procedures, forms, and other quality documentation.
• Represent QA Operations at plant and multi-site scheduling, disposition, and project meetings.

Required Skills

• Experience in Quality Operations within a GMP environment.
• Proven ability to conduct investigations and manage product manufacturing quality processes.
• Experience supporting Management Review through data generation and metric maintenance.
• Ability to interpret and apply procedural and regulatory guidance in ambiguous situations.
• Strong analytical and written communication skills.
• Master's Degree with 5+ years of GMP experience, OR Bachelor's Degree with 7+ years of GMP experience, OR High School Degree with 11+ years of GMP experience.

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 applying GMPs in conformance to U.S. and EU standards.

Key Skills

Education

Any Graduate