Daniel Taylor

Senior Technical Operations Specialist Ii @Purdue Pharma L.P

Lead Investigator: Spearhead comprehensive investigations into manufacturing and packaging deviations, meticulously documenting findings in concise and impactful investigation reports.• Root Cause Expert: Expertly apply root cause analysis methodologies and problem-solving techniques to determine the underlying causes of GxP deviations, minimizing recurrence and maximizing process efficiency.• CAPA Management: Lead cross-functional teams in the development, implementation, and monitoring of effective CAPAs, ensuring the sustainable resolution of identified issues and driving continuous improvement.• Process Optimization: Proactively identify opportunities for process enhancements based on investigation findings, contributing to increased productivity, reduced waste, and improved product quality.• Documentation Authority: Author, review, and maintain standard operating procedures (SOPs) and other controlled documents, ensuring alignment with current best practices and regulatory requirements.• Change Management: Initiate and manage change controls for Manufacturing and Packaging operations, ensuring proper risk assessment, impact evaluation, and successful implementation.• GxP Collaboration: Collaborate effectively with subject matter experts (SMEs) across various departments to ensure comprehensive cross-functional evaluations and consistent application of GxP principles.• Controlled Substance Stewardship: Maintain strict adherence to controlled substance documentation and accountability procedures, demonstrating vigilance in preventing diversion and theft.• Product Impact Assessment: Lead investigations to evaluate potential product impact, incorporating input from diverse departments to ensure a comprehensive and data-driven assessment.• CAPA Lifecycle Management: Oversee the entire CAPA lifecycle, from creation and execution to effectiveness monitoring, ensuring the sustained resolution of identified issues.