Pleio IncQuality Assurance Manager
Apr. 2015 - Jan. 2021United States, Hollywood
• Developed Standard Operating Procedures (SOPs) and comprehensive training guides for projects that required coordination across multiple departments.
• Identified key performance indicators (KPIs) and introduced preventive and corrective measures to address the root causes of quality issues and delivery delays.
• Formulated processes, policies, and procedures for various areas within the department, leading to the seamless integration of production and quality assurance processes.
• Designed workflows, crafted manual test scripts, and developed comprehensive testing plans and strategies.
• Oversaw Quality System compliance and management, ensuring all standards were met.
• Authored detailed reports and papers, and organized supporting documentation for easy reference.
• Offered strategic regulatory advice to both internal and external stakeholders, ensuring compliance with FDA regulations.
• Regularly reviewed the organization's internal practices to ensure adherence to government regulations.
• Designed and implemented an audit program capable of identifying potential risks and assessing compliance requirements.