JOE DUENAS

• Conducted over five hundred comprehensive investigation reviews, including drafting and granting approvals annually, ensuring thorough analysis and adherence to protocols.
• Developed a range of standardized investigation templates for network utilization, streamlining processes and enhancing consistency across the board.
• Conducted comprehensive annual and quarterly reviews of the EM trend files to ensure FDA readiness and perform thorough trend assessments across thirty PET sites.
• Executed meticulous HEPA certification evaluations for thirty PET sites, confirming compliance and analyzing trends in facility performance.
• Designed and implemented an effective investigation tracking system to meticulously monitor network performance, enabling proactive identification of trends and issues.
• Authored and critically evaluated Standard Operating Procedures (SOPs), ensuring clarity, compliance, and alignment with industry best practices.
• Provided expert guidance on change management processes, ensuring strict adherence to regulatory requirements and maintaining high quality standards.
• Collaborated effectively with cross-functional teams to facilitate prompt issue escalation and resolution, significantly enhancing overall operational efficiency.
• Mentored junior colleagues in best practices for quality assurance, cultivating a robust culture of quality and compliance within the organization.
• Delivered comprehensive training to colleagues, managers and principal specialists, on job responsibilities, promoting cross-functional productivity and cohesion.

• Oversaw audits and approvals of incoming material quality inspections, sterility testing, and drug product processing, ensuring adherence to cGMP standards.
• Successfully executed and audited change controls, equipment and personnel qualifications, significantly reducing out-of-specification results and non-conformances.
• Trained personnel on quality assurance best practices and the importance of cGMP compliance, improving overall site quality culture.
• Developed and maintained comprehensive documentation for equipment status and qualification, standardizing reporting practices across multiple sites.

Conducted comprehensive audits and investigations related to production processes, ensuring alignment with regulatory standards and internal procedures.

• Improved operational efficiency by analyzing existing processes and implementing effective solutions to production challenges.
• Supported the implementation of standardized training and quality assurance processes for new employees, enhancing team performance and product quality.
• Updated SOPs and manufacturing records to reflect current validated processes and to prevent adverse product impact.
• Key contributor in the implementation of the Palltronic Filter Integrity Testing Units.
• Helped foster a culture of ‘Right the First Time’ to improve quality culture and reduce the number of errors.
• Utilized Trackwise and SAP for data management and tracking