Ivonne Rodriguez Gamboa

Lead Quality Assurance operations, ensuring compliance with corporate standards across cellulose, collagen, and fibrous casing products. Mentor and supervise QA Technicians, promoting a high-performance, accountable, and collaborative team culture. Oversee GMP, sanitation, HACCP, and food safety compliance across manufacturing operations.

Ensure effective verification of sanitation programs, GMP practices, and batch documentation through QA oversight and review. Drive continuous improvement initiatives through data-driven quality analysis, trend monitoring, and corrective actions. Partner with Production and Technical Services teams to resolve quality issues, manage customer claims, and implement preventive measures.

Maintain QA documentation, SOPs, and calibration records, ensuring regulatory and corporate compliance. Serve as Acting Quality Director, supporting strategic decisions and operational alignment.

Directed QA and regulatory compliance across Central American and Caribbean markets, ensuring operational efficiency and risk mitigation. Conducted warehouse and laboratory audits, optimizing processes to increase product integrity and operational effectiveness. Developed and delivered training programs for operational teams, building a culture of accountability and continuous improvement.

Collaborated with cross-functional teams to resolve operational and quality issues, improving KPIs such as batch performance, compliance scores, and production efficiency. Led cross-border QA programs that improved regulatory compliance and reduced shipment delays by 18%.

Coordinated end-to-end product launches with R&D, QA, Regulatory, Supply Chain, and Production teams. Managed scale-up processes, ensuring regulatory compliance and operational readiness. Conducted risk assessments using FMEA and reviewed MSDS, labels, and technical datasheets.

Delivered launch readiness training to cross-functional and operational teams. Successfully launched 15+ new products across multiple markets, achieving on-time delivery and zero regulatory non-compliance. Reduced product launch cycle time by 12% through process standardization and cross-functional coordination.

Performed comprehensive audits of manufacturing, warehousing, and laboratory operations. Performed sanitation verification and GMP audits across manufacturing, warehousing, and laboratory operations. Verified batch documentation and manufacturing records for compliance with established procedures and quality requirements. Verified compliance with GMP, GLP, SOPs, and regulatory requirements; issued CAPA reports and monitored effectiveness.

Supported HACCP compliance and food safety verification activities. Supported cross-functional teams to implement improvements, maintain audit readiness, and prepare for third-party inspections. Improved internal audit scores by 20% through structured follow-ups and targeted training programs.

Conducted chemical and physical analysis of raw materials and finished products. Assisted in laboratory calibration, process validation, and investigation of non-conforming products. Maintain strict adherence to GMP, HACCP, and laboratory safety standards.

Educated patients on medication safety and proper storage. Managed inventory, labeling, and recordkeeping.