Description

Own product disposition and lot closure for commercial and clinical products in a GMP environment.

This role is on-site.

Responsibilities

• Review batch-related documentation and shipment records to ensure control during product disposition and lot closure.
• Provide QA oversight for deviations, CAPAs, and change records to ensure timely initiation, investigation, and resolution.
• Support investigations and batch record reviews while verifying process control measures during manufacturing.
• Maintain product disposition metrics for Management Review and generate necessary data reports.

Required Skills

• 5+ years of GMP experience with a Master's Degree, OR 7+ years with a Bachelor's Degree, OR 11+ years with a High School Degree.
• Proven experience conducting investigations and managing product manufacturing quality processes.
• Hands-on experience in Quality Operations within a GMP environment.
• 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.

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