QC Investigator

The QC Investigator provides the leadership and technical expertise necessary to establish robust investigations during laboratory events, out of specification, and out of trend events. This position utilizes knowledge of chemistry, cGMP, and analytical techniques to guide the investigation process and facilitated the completion of Phase I and Phase II reports.

The QC Investigator will work with cross functional teams to develop proper corrective and preventive actions for confirmed OOS events. The incumbent will also support the trending associated with quality investigations, Key Performance Indicators (KPIs) and / or other Quality Metrics. This role will support regulatory and customer audits and interact with the customer to regarding laboratory investigations.