Dynamic and highly reliable Chemist with over 10 years of experience in Chemist Multidiscipline areas. Capable leader and decision maker. Strong problem- solving, service,troubleshooting and project management. Able to work under pressure and managing change,complexity and dealing with ambiguity.
Computer System Validation Supervisory Experience Problem Solving Skills
Computer based programs:
Office 2010, Project, Minitab and
Bilingual (Spanish and English) Team-oriented, proactive and self- motivated
•Providing direct supervision and overall leadership to Validation personnel. This supervision includes assignment and scheduling of work, monitoring of performance, coaching and mentoring, assurance of the overall quality of the work performed by the validation team.
•Coordinated validation process for manufacturing equipment Cost estimates for projects, scheduling and cost control functions.
•Developed Protocols for Equipment Qualification (Firmware), Design Specifications, Installation Qualification, Operational Qualification, Performance Qualification, Legacy System Protocols, and Equipment Standard Operating Procedures
•Performed Laboratory Audits for manufacturing companies to ensure Regulatory Compliance according to Current Good Laboratory Practices
•Managed the start-up project of the Analytical Laboratory for VWR International in Puerto Rico (Facilities Validation, Equipment Validation, Computer Validation, and Quality Assurance Platform)
•Represented as subject matter expert in Puerto Rico the ThermoFisher Instruments FTIR and FTIR Microscope line and Software Applications
•Managed and coordinated the QC/QA laboratory safety
•Performed equipment validation and calibration for analytical testing
•Supported and trained Wet Chemistry analysis to Raw Material Laboratory (Heavy Metals, E.P. Identifications, Humidity quantity using Karl Fisher, pH analysis)
•Analyzed packaging components using FT-Infrared Spectroscopy
•High Performance Liquid Chromatography (HPLC) identification and potency of active ingredients.
Administration (Technology Management)
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