Nataly Hernandez Email and Phone Number

• Develop, coordinate, and perform internal and external quality audits to verify compliance with ISO Standards 22716, governmental agencies, Organization QMS, and cGMP, following up on the corrective actions CAPA closure.• Responsible for US regulatory submissions, including FDA drug and establishment registrations, renovation of Florida and Arizona State licenses, notarized NAFTA/USMCA documents, Free Sale (CFS), and GMPs apostille for foreign countries as required by the customers.• Manage the deviation and out-of-spec process (OOS) for the OTC cosmetics products manufactured, leading the investigation, and coordinating cross-functional team for the evaluation of the manufacturing process, raw materials… ensuring the CAPA is implemented, and the process is completed.• Prepares, and reviews OTC cosmetics batch records including the data correlation of test results (analytical and microbiology) for release and timely disposition of bulk for filling, WIP for packaging, and finished goods for shipment.• Manage the OTC change control process keeping the traceability of the implementation of all changes made and evaluating the regulations impacting the OTC cosmetics products distributed in the USA, Canada, and European markets, implementing plans for the remediation of identified compliance gaps as required.• Conduct the Mock Recall, and Annual Product Reviews (APRs) for OTC products compliance with the Long-Term Stability Program (LTS) and prepare the final report for Top Management review. Administers the Stability Chamber records, temperature and humidity mapping, and annual calibration plan.• Coordinate the Manufacturing Validation Program through protocol creation, execution, and report release ensuring FDA and external regulations requirements are met.

• Responsible for Bulk submissions are sent within 24 hours of production to the customer meeting their requirements and follow-up on the final approval.• Coordinate the investigation for formula deviations with the interested parties, providing the appropriate information to determine the RCA and properly document the NCRs, destruction requests, and CAPAs as applicable.• Mentor, manage and lead the quality laboratory team members to ensure bulk manufacture release and area plan complies with internal standards, and federal regulations and meet customer satisfaction.• Update laboratory SOPs, STMs, and WKI and implement continuous improvement.

• Coordinate the hourly inspection activities of the products manufactured for method and GMPs compliance reporting non-conformances, documented deviations, and follow up on the corrective actions.• Audit Production and Quality Control to ensure that coding requirements are followed, and specifications are used correctly, including TBOM, product standard, spectrum, SOPs, and testing methods.• Creation and update of test/inspection methods and work instructions for the production and QC area mentoring and training the team members as needed.Responsible for samples collection for micro testing, customer samples, and approval of waiver request prior to evaluation of formula historical data. Update the product status and final release for shipment.

• Identify current and potential product shortages and advise interested parties of status and recovery plans. Monitor and optimize inventory levels to ensure availability while minimizing excess stock and obsolescence risks.• Coordinate all Quality control-related activities for sweet wine, dry-cooking wine, and rum in the following areas: Incoming Inspection, In-process Inspection, and Finished goods. Analyzes reports and defective products to determine trends, recommends corrective actions, and implements training programs.• Responsible for the creation of the weekly production schedule monitoring demand requirements and operations plan, master schedule, raw materials availability, customer orders/samples, and their delivery performance against the plan adjusting as needed.• Monitor raw material quality performance and their appropriate distribution for the wide variation of rum manufactured ensuring the follow up of the GMPs from the supply chain and throughout the product development.

• Developed and updated policies and procedures, maintaining compliance with statutory, regulatory, and local guidelines. Preparing data analysis and documentation to report all production plant performance KPIs.• Ensure the flow of materials, and resources necessary for production, and plan methods to improve efficiency by analyzing products, components, materials, and equipment for the purpose of understanding and predicting failures.