Proven QA Manager at Salud Natural Entrepreneur, Inc., adept in Agile methodologies and cross-functional team leadership, significantly enhanced product quality and customer satisfaction. Skilled in process improvement and risk assessment, I spearheaded initiatives that streamlined testing and compliance, leveraging my expertise in quality assurance and team building to drive operational excellence.
Experience in sales and marketing providing advertisement of products, allergens for consumer awareness, proper sanitation and handling of foods during demonstration ensuring customer satisfaction and regulations of food handling guidelines.
Maintained product in proper controlled storage conditions, with routine temperature monitoring and documentation, some supply chain and procurement inventory and communication to warehouse personnel. Food Safety And Handling certifications completed.
Implemented, configured and maintained functionality of LIMS. Complied with SOP’s, performed troubleshooting of the LIMS system. Created new product configurations, updated existing product configurations and tracked current version changes in Documentum.
ERP systems (SAP) used for investigation of raw material components in finished product material.
Worked with Document Coordinators and the Quality Assurance team to ensure GLP and GMP requirements of the LIMS system procedures were accurate. Developed LIMS training modules using cross functional training. Collaborated as a qualified trainer with the Document Control department and colleagues to ensure proper documentation is fulfilled prior to training sessions.
Supported site changes, global change management and validation process. (test scripts)
Ensured administrative management functions-Quarterly Change Request, and assisted the manager with annual LIMS periodic reviews to maintain compliance of users' access.
Led, documented and supported monthly audits, then transitioned documents through an IBM interface system for the facility reviewer.
Prepared, maintained, and monitored quality system records establishing consistency in application while leading a project with a limited scope where quality decisions were coordinated between different quality and other functional areas.
Performed sampling, inspecting, testing and dispositioning of incoming commodities, in-process and finished product, stabilities and complaints per specifications or protocol. Analyzed data, evaluated results, and drew conclusions with disposition of material that involved initiating and performing investigations per OOS or nonconformance through Exception Events, Change Request and/or CAPA documentation.
Maintained certification in assigned job responsibilities and completed timely LMS training while performing daily operations, data management, problem solving and process and/or continuous improvements.
Implemented, maintained and supported the quality policy and ensured compliance to site level policies and procedures through individual and team contribution.
GLP applied consisting of ordering, CR Closeout audits and disposal of hazardous materials in the Chemistry Lab using MSDS and CHAP as part of the EH&S Program.
Trained and updated existing SOPs through change management control to align work instructions in compliance with federal regulations.