Responsibilities:
Lead and facilitate root cause investigations for quality and safety events, ensuring timely, thorough, and compliant resolution.
Collaborate with cross-functional teams to support and mentor staff on investigation methodologies and technical writing best practices.
Author and review technical documentation including investigation reports, impact assessments, deviations, change controls, CAPAs, and standard operating procedures (SOPs).
Drive continuous improvement initiatives through data analysis, Kaizen events, and KPI-driven discussions to enhance manufacturing performance.
Perform risk and impact assessments to support decision-making and ensure regulatory compliance.
Ensure adherence to GMP standards and internal quality systems while promoting a strong culture of safety, quality, and accountability.
What You Need to Succeed (minimum qualifications)...
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