Summary
The Lead Investigators responsibilities will be to lead and manage all levels of deviations and related reports to closure within the established timelines for the manufacturing department. Will conduct comprehensive investigations to determine potential product impact, identify root cause and implementation of corrective and preventative actions in accordance with established procedures and timelines.
Job Function and Description:
• 80% Create/monitor/manage/author deviations, Out of Specification (OOS?) and Out of Tolerance (OOT?) and environmental alert actions Monitor GMP investigations progress and support process to closure. Work cross-functionally to assess and analyze deviations and investigations to determine impact and root cause. Escalate conflicts that arise.
• 10% Identify, initiate and track corrective and preventative actions for investigations, OOS and OOT
• 10%Track and identify Quality System and root cause trends and identify opportunities for operational improvements
Key Skills, Abilities and Competencies: Strong written and verbal communication skills demonstrate high-level of professional and business judgment when communicating with cross-functional teams and others at all levels of the organization must be proficient with Microsoft Office applications, including Word, Excel and Power Point. Experience with more advanced document management applications a plus (including but not limited to TrackWise and SAP)