The Lead Investigator helps investigate quality issues in manufacturing and quality laboratories, including manufacturing deviations, out-of-specification results, and atypical results. They identify root causes and suggest corrective action plans. The role involves completing investigations in the site investigations electronic system, coordinating CAPA, and driving on-time closure of investigations.
They perform investigations for manufacturing-related deviations using DMAIC tools and collaborate with internal departments, outside vendors, and regulatory bodies. They also assess the impact of events on products, equipment, or processes.