Implement a major LIMS upgrade, enhancing system performance and user experience while reducing paper based inspections.Manage the Laboratory Information Management System (LIMS), ensuring optimal performance, reliability, and security. Administer user accounts, roles, and permissions to control access and maintain data integrity.Configure and customize LIMS modules to meet the specific needs of the laboratories for Incoming, In-process, Finished Goods and Micro testing, including workflows, data entry forms, and reporting templates. Work with cross-functional teams to ensure the system aligns with lab processes and regulatory requirements.Oversaw the accurate and secure collection, storage, and retrieval of laboratory data. Ensure data integrity through validation checks, and troubleshooting of system issues.Identify opportunities to enhance laboratory efficiency and data accuracy through LIMS functionalities. Implement new features and automated processes, to reduce manual data entry errors and faster data processing times.Ensure the LIMS complies with regulatory standards such as FDA, GLP, and ISO requirements. Managed and documented changes, upgrades, and system configurations following industry best practices and company SOPs.Supervising Trace staff and ensuring that workflows of FG Releasing are efficient by monitoring performance management, and ensuring weekly release goals are met.Responsible for leading projects that involve integrating digital technologies into business processes to enhance efficiency and drive innovation. Managing the project budget, ensuring the project is delivered within financial constraints. Leading change management efforts to ensure smooth adoption of new technologies and processes across the organization.

Led a team of quality engineers, quality technicians and analysts in a high-throughput laboratory environment, ensuring the accurate and timely completion of all testing and analysis activities. Ensured that all laboratory procedures and processes adhered to industry standards and regulatory requirements (e.g., FDA, ISO 17025). Developed and maintained Standard Operating Procedures (SOPs) to ensure consistent quality results. Oversaw the collection, analysis, and interpretation of laboratory data trough the Administration of LabWare LIMS. Prepared comprehensive reports for senior management, highlighting key trends, potential risks, and areas for improvement.Worked closely with the R&D, Manufacturing, and Quality Assurance teams to support product development, process validation, and root cause investigations. Provided expert input on the quality aspects of new projects and initiatives.Developed and conducted training programs for laboratory staff, focusing on best practices in testing procedures, and quality management. Mentored team members to enhance their technical skills and career growth.- Successfully led the laboratory through multiple regulatory audits maintaining full compliance with all applicable standards.- Recognized by senior leadership for outstanding contributions to laboratory operations and continuous improvement initiatives.

Quality Management Systems, Regulatory Compliance, Process Improvement, and Cross-Functional Team Leadership Management.Lead quality initiatives, collaborate with cross-functional teams to optimize manufacturing processes, and ensure compliance with industry standards. - Led and manage quality assurance and Laboratory activities - Ensure compliance with FDA regulations, ISO standards, and other industry requirements. - Collaborate with R&D, manufacturing, and regulatory teams to ensure seamless product launches and transfers. - Conduct root cause analysis and implement corrective actions to resolve quality issues.

Managing effectiveness and efficiency of Laboratories for product evaluation in Raw Material Incoming inspection and Finished goods Inspection.

-Quality Management support in Inspection and Testing areas. - Coordinator of Incoming inspection raw material process:- Communication with external and internal suppliers. - Certificates and accomplishments with material specifications.- Bioburden and Dose Audit testing administration.- CAPA and Non conformance process follow up.- Validation process execution trough IQ, OQ & PQ focused in inspection equipment.- Test Method validationsCertified on Lean and Six Sigma Green belt

Non conformances & CAPA System management administrator, development of analysis, trends and follow up of Non conformances, Complaints and CAPA activities, QA Dashboard Reporting to Worldwide and local Quality Systems, development of CAPA review Board and Management Review presentations.

Design and creation of detailed technical drawings and schematics, collaborating with engineers to ensure system designs met project requirements, and troubleshooting issues during the installation and testing phases. Strong skills in utilizing CAD software, conducting system performance evaluations, and ensuring compliance with Automotove industry standards. Problem-solving abilities and attention to detail, contributing to the successful completion of multiple projects.

Ensuring the quality and compliance of products throughout the manufacturing process. Inspections of raw materials, in-process components, and finished products using various measurement tools and techniques.Execution of tests to verify product specifications, documented results, and identified any deviations from quality standards. Collaboration with production teams to address quality issues, implemented corrective actions, and contributed to continuous improvement initiatives. Analytical skills, attention to detail, and ability to maintain high-quality standards in a fast-paced environment.