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PHONE NUMBER AVAILABLE / PHONE NUMBER AVAILABLE EMAIL AVAILABLE Summary of QualificationsQC Laboratory Analyst with over nine years of experience in a regulatedQuality Assurance and Quality Control environment in the manufacturingindustries. Excellent proficiency performing chemical and microbiologicalanalysis and sampling for raw materials, in process, finished product,water, environment, cleaning stability and validations samples. Strongskills performing analytical data review and approval, laboratory equipmenttroubleshooting, calibrations/PM, laboratory investigations support, CAPA'scompletions and internal audits participation. Extensive knowledge incGMP's, cGLP's, pharmacopeias analysis (USP-EP-JP), aseptic techniques andcontinuous improvements systems. Capable of managing different prioritieswith aggressive timelines. Flexible and focused on team work with excellentanalytical and leadership skills. A highly motivated individual capable ofstrengthening all applicable regulations and quality systems. Ability toapply critical thinking to resolve complex issues and day-to-daysituations. Hands on experience in computerized programs such as: Empower,Trackwise, SAP, Microsoft Word, Excel, Power Point, Internet Explorer andOutlook. Bilingual English and Spanish.Technical Skills: Analytical and Microbiology Testing and Instrumentation |GC | HPLC | FTIR | RAMAN | UV-VIS-Spectrophotometers | Dissolution | TOC |pH Meters | Conductivity Meters | Density Meter | Polarimeters | MeltingPoint Apparatus | Karl Fischer | Titration Meters | Volumetric TitrationMethods | TLC | Viscometers | Moisture Analyzer |Centrifuges | Ovens/Muffles | Analytical/Micro Balances | Autoclave | Micropipettes |Microscope | RCS | Sterile Hoods | Incubators | Professional ExperienceOlay LLC / Procter & Gamble, Cayey, Puerto RicoQC Laboratory Analyst / Reviewer 2011 - present . Execute chemical and physical laboratory analysis of raw materials, in process and finished products. . Analyze stabilities, complaint samples and non-conforming material samples. . Conduct sampling and analysis for RO and USP plant water systems. . Perform Cleaning Swabs analysis supporting manufacturing areas. . Review analytical data and release for raw materials. . Execute method transfers and method validation protocols. . Perform raw materials sampling following aseptic techniques. . Prepare chemical solutions following corresponding methods and pharmacopeias. . Perform calibrations, preventive maintenance and troubleshooting of the required laboratory equipment. . Participate in laboratory equipment qualifications. . Maintain the laboratory solutions inventory. . Provide support to laboratory investigations and CAPA's resolutions. . Prepare and revise Standard Operating Procedures.Accomplishments: . Implemented 5S audits in laboratory area. . Reduced 90% the cost in parts and time for HPLC and GC by the creation and implementation of the maintenance routine.Autoridad de Acueductos y Alcantarrillados, Can?vanas, Puerto RicoDrink Water Plant Operator 2010 - 2011 . Executed chemical and biological tests for water samples at various stages of treatment. . Documented and prepared analysis reports. . Completed process and testing audits. . Handled high-tech equipment, control pumps, valves and computer PLC that moves water through the numerous treatment processes. . Performed laboratory and field equipment set-up, calibration, maintenance and troubleshooting.Pall Life Sciences, Fajardo, Puerto RicoQC Laboratory Analyst 2006- 2010 . Executed biological and chemical laboratory analysis for the product samples during in process and final stages. . Performed endotoxin (LAL), total organic carbon (TOC), conductivity, pH and Chlorine levels. . Conducted environmental analysis, bacterial and mold contamination tests. . Executed standardized biological tests and laboratory analyses to evaluate the quantity or quality of physical or chemical substances in fluids from filters. . Conducted sample analysis for validation process and product samples during intermediate stages and final stages. . Conduct sampling and analysis for RO and USP plant water systems. . Perform Cleaning Swabs analysis supporting manufacturing areas. . Analyze complaint samples and non-conforming material samples Executed method transfers and method validation protocols. . Prepare chemical solutions following corresponding methods and pharmacopeias Prepared final reports to ensure accurately and precisely completion of method transference. . Performed laboratory and field equipment set-up, calibration, maintenance and troubleshooting. . Evaluated product incidents and deviations. . Provided support to laboratory investigations and CAPA's resolutions. . Prepare and revise Standard Operating Procedures. EducationUniversity of Puerto Rico, Rio Piedras CampusBachelor of Natural Science - Major in Microbiology Trainings / Certifications . Laboratory Analyst Certification in Technique Modules: Pipetting, Weighing Technique, HPLC/GC Chromatographic Techniques, Swabs Cleaning, TOC, Spectrophotometry, and USP/NF Use & Interpretation . Empower 3 . Agilent's GC and HPLC Troubleshooting . Waters HPLC and GC troubleshooting . cGMP's & GLP'S . 5S - Continuous Improvements . High Performance Organization . Drinking Water Operator . Aseptic Techniques . Safety certifications: DTOP, RCRA, OSHA . Waste Management Program . Biomedical Waste . EH&S Personal Protective Equipment |
