Fabio Quitian Email and Phone Number

• Managed, led and oversaw Quality Unit Operations. • Managed analytical and microbiological laboratory operations.• Led cross functional teams for continuous improvement in Quality systems. • Managed the hiring, staffing, training and development of Quality Unit in the manufacturing plants.• Led and managed 3rd party audits including but not limited to: FDA, USP, UL-STR, USDA, City Specific, Gluten Intolerance Group (GFCO), USDA Organic Program, International, State and Federal regulatory agencies.• Led, coordinated and conducted internal audits for Manufacturing, Packaging, Warehouses and raw material manufacturing sites. • Implemented strategic planning and analysis to identify areas for cost control and cost improvement, saving large amounts of resources and increasing profits.• Analyzed and interpreted statistical data into evidence-based strategies for continuous improvement, yielding measurable advances in operational outcomes.• Led the HACCP team for AZ, FL, and NY sites. • Developed Food Safety Plan for Raw Material manufacturing site in AZ. • Monitored workload, project timelines, and adherence to set goals, while providing critical support• Reviewed, verified and approved formula changes and master batch records• Deployed corporate initiatives on regards to Quality and Safety• Fomented professional growth within the Quality team to improve performance and understanding of cGMP & cGLP processes for a team of 92 quality professionals across two campuses.• Managed complex deployment of teams across the network to execute organizational goals and attain KPIs. • Managed the review, edition and approval of quality procedures and protocols• Managed the MRB process for FL and NY Manufacturing sites• Managed, reviewed and disposition Out of Specification (OOS) Results for FL and NY Operations • Implemented and influenced large groups to execute corporate initiatives while maximizing productivity and sustaining corporate rules and policies

• Managed the hiring, staffing, training and development of Quality Auditors in the manufacturing plant and packaging facility.• Reviewed, verified and approved formula changes and master batch records for manufacturing of solid dose in the AS400 system.• Managed the deployment and implementation of the internal audit program for NBTY Global including Canada sites. • Participated actively and efficiently in GEMBA and DDS (Daily Direction Setting) meetings to successfully resolve issues on the manufacturing plant.• Fomented professional growth within the Quality team to improve performance and understanding of cGMP processes.• Assisted in generating new SOPs, and revised current SOPs to reflect new changes in regulatory matters and procedures ensuring that those affected by the modifications were trained properly.• Set objective goals for the quality auditors providing the tools for completion of goals, both theoretical training and on the job training.• Planned, and implemented methods to avoid and diminish the amount of discrepancies affecting FPQ for the manufacturing facility• Led and managed 3rd party audits.

Supervised the activities of the Quality Unit in the manufacturing facility ensuring compliance of CFR 21 Part 111 Regulations.Fomented professional growth within the Quality team to improve performance and understanding of cGMP processes.Reviewed, approved and financially closed batch records in the AS400 System.Resolved quality issues on the Manufacturing floor in a timely manner.Reviewed and approved manufacturing deviations, non-conformances, and investigations to determine root causes of quality issues.Assigned duties and tasks in an effective manner maintaining priorities and timelines, assuring that the responsible party delivered high standard and quality information.Led, trained, and motivated the quality unit by implementing new tools for process understanding.Assisted the quality team achieve its goals by coaching the individuals to better use their skills and time management.Scheduled and coordinated to ensure coverage for manufacturing activities.Assisted in generating new SOPs, and revised current SOPs to reflect new changes in regulatory matters and procedures ensuring that those affected by the modifications were trained properly.Provided training to the Quality and Manufacturing associates in a vast array of procedures both new, and exciting while maintaining documentation records for all training implemented.Monitored individual performance and maintained records.Periodically assisted upper management in duties of a higher position.Assumed responsibilities of the Quality manager during their absence or by request.Assisted in the disposition and release of finished goods from Co-packers ensuring high quality standards and proper documentation of the process.Assisted in performing official in-house audit for NBTY Florida Packaging, and Manufacturing facilities.

Managed daily operation of 70+ members in the Manufacturing/Packaging department and six corresponding Product lines. Scheduled with other departments to ensure coverage for manufacturing activities.Ensured that cGMP’s and regulations were followed during raw material and packaging component receipt, storage, packaging, distribution and shipment.Maintained OSHA regulations and safety programs resulting in zero lost time and zero recordable incidents. Identified benchmarks for minimum waste and maximum allocation of resources. Coordinated and ensured reviewing of manufacturing and packing records in a timely manner.Analyzed internal processes to develop short and long term company objectives, production Capacities and opportunities for improvement for cost reduction. Managed standardized processes to maintain unilateral manufacturing across all six product lines. Planned scheduled manufacturing productions runs based on forecast. Coordinated with the Planning Department to meet product demand in a timely manner. Coordinated with the Purchasing department and assisted in controlling usage of raw materials and packaging components. Coordinated with the Quality Control lab as well as Quality Assurance department to produced only high quality and standard adherent products. Worked as a liaison with the R&D lab to better manufacture newly developed products as well as modifying current practices to become more efficient and cost effective. Led, organized, and motivated all operations employees in a manner that positioned the facility to meet company goals. Coordinated the flow process of contracted manufacturing processes from blending to packaging. Ensured management goals were achieved through proper planning and implementation of project objectives, timelines, and customer satisfaction goals. Optimized manufacturing operations by establishing internal protocols and following FDA guidelines.

Developed & implemented policies & procedures (SOP) for Quality Assurance (QA), Compliance, Production, Quality Control (QC), Purchasing, & Warehousing. Audited VPX 3 facilities to comply with FDA,& international quality standards. Conducted quality & sanitation audits at contractor's manufacturing plants. Served as liaison between third party auditors from the State, Federal level, and international agencies. Conducted training for all manufacturing employees in groups of 45+ persons. Organized, and motivated all operations employees in a manner that positioned the facility to meet company goals. Coordinated in investigation of consumer complaints. Using CAPA ( Corrective Action, and Preventive Action) Supervised quality assurance inspectors, material handler, document control clerks, and the sanitation crew. Attained food export permits from the FDA, USDA, and APHIS Veterinarian Services. Provided international documentation including health certificates, certificate of analysis, certificate of free sale (CFS), certificate of good manufacturing practices (GMP), export certificates, and ingredient declarations. Studied microbiological results of manufactured items, and raw materials to verify their adherence to quality standards. Organoleptically tested manufactured items to verify their adherence to established specifications. Evaluated manufactured items for "Release to Market" after reviewing adherence to specifications both analytical, and organoleptical. Monitored the processes from 3rd party manufacturing plants for release of bulk product to be packaged. Coordinated the flow process of contracted mfg processes from blending to packaging. Ensured an effective transfer of new production into manufacturing in conjunction with R&D, QC/QA.