● Initiated, tracked, and managed Corrective and Preventive Action (CAPA) processes from identification to resolution, ensuring timely and effective issue resolution.
● Collaborated with cross-functional teams to investigate root causes, develop corrective and preventive actions, and implement solutions to prevent recurrence of issues.
● Monitored CAPA progress and ensured that actions were completed within established timelines, maintaining compliance with industry regulations and internal standards.
● Designed, developed, and implemented a custom project management tool in Smartsheets to streamline workflow, improve team collaboration, and enhance project tracking of Drug Substance Manufacturing.
● Created a database and reports within smart sheets for projects below $25000 to consolidate best plant metrics of Cost Savings, Cost Avoidance, and Sustainability.
● Assisted in the development standardized risk management plan templates.
● Assisted in the Manufacturing Epogen Product following GDP and SOP Guidelines.