Sudeshna Kanungo

• Conduct lot release for finished products by reviewing batch records, analytical test reports and issue CoA for finished product lot.
• Release raw material lots by reviewing specifications and certificates for compliance.
• Review material qualification summary and update qualification status.
• Host customer audits alongside with compliance manager.
• Participate in internal audit program.
• Review and approve quality events.
• Collaborate with cross-functional team to help with root cause analysis and investigation report writing.
• Conduct complaint investigation and generate customer response.
• Conducts root cause analysis for quality issues, driving resolutions that improved overall product integrity.
• Initiate Effectiveness Check (EC) criteria after CAPA closure. Perform and maintain EC program.
• Provides regular updates to team leadership on quality metrics.
• Mentor junior QA staff on best practices related to QA daily operations.
• Review technical documentation for accuracy and completeness.
• Collaborate with all operational departments on specific QA standards and ensure maintenance of standards.

• Managed and mentored a team of 10 technicians in Quality Assurance and sanitation teams
• Managed Quality Assurance program to ensure top high product quality and customer satisfaction.
• Hosted Regulatory (SQF, Kosher, FDA) and customer audits.
• Coordinated and conducted internal audits.
• Conducted annual validation tests for critical processes controls.
• Conducted GMP and safety trainings.
• Maintained Supplier Approval and Management program. Collaborated with providers to implement supplier management software.
• Handled customer inquiries and complaints.
• Process owner for CAPA program.
• Sourced alternative cleaning supplies and services to keep up with ongoing supply chain issues during Covid-19.
• Streamlined QA record keeping procedures by creating digital documents and logs.
• Updated FDA registration for facility.
• Processed export certificates for international shipments in collaboration with Sales and Logistics.
• Hosted contractors for equipment calibration and repair alongside the maintenance team.
• Facilitated in product development and launching in collaboration with Regulatory, Marketing and R&

• Hired, trained and supervised Quality Assurance and Sanitation teams.
• Created HACCP flowcharts, SOPs and test methods for new products.
• Created SOPs and test methods for new ingredient testing.
• Hosted regulatory (NOAA, WSDA), certification agency (NSF) and customer audits.
• Maintained SQF certification program.
• Conducted laboratory testing, namely ELISA for Histamine in tuna.
• Conducted EM sampling, ATP and Allergen swabbing during process changeover.
• Managed CAPA program.
• Improved existing supplier management program to accommodate regulatory program requirements and streamline documentation.
• Coordinated workplace safety trainings, such as, forklift operations, first aid, ammonia awareness and chemical spillage.