Senior Compliance Investigation Specialist II

Requirements

• Provides guidance, coaching and feedback to all groups involved in initiating, completing and conducting manufacturing investigations and CAPA analysis.
• Gathers and analyzes historical data to identify trends and root-cause of manufacturing deviations.
• Develops and recommends corrective and preventive actions to prevent/eliminate recurrent discrepancies and leads its implementation in manufacturing.
• Acts as the primary contact in the resolution of conflicts and differences resulting from the resolution of MIRs.
• Collaborates in the design and deployment of trainings to educate employees on how to report, initiate, conduct and close an investigation.
• Leads efforts to educate leaders and employees on OPEX methods, practices and tools.
• Leads process improvement initiatives that increase quality/compliance, efficiency and safety within the Sterile Product Manufacturing facility