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Manufacturing/Quality/Validation position
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Profile
• Highly organized, diligent and responsible, able to create and execute complex projects and programs to meet organizational needs
• Analytical, conceptual and logical thinker, able to convey information with clarity, patience and terminology appropriate to diverse audiences.
• A dedicated team player, committed to providing high-quality support and excellent problem-solving skills to all organizational levels.
• J2 Visa Status with full approval work permission.
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Highlights of Qualifications.
• Experienced lab and Metrology Technician / Quality Assurance, with chemical engineering knowledge.
• Good skills in quality tools: Lean Manufacturing Operations. FMEA, Pareto Charts, Fishbone Diagrams, Statistical Process Control. . Quality and Certificate Auditing.
• ISO leadership , implementation and management: ISO 17025 (Measurement and Calibration Laboratories), ISO 13485 (Medical Devices), ISO 10012 (Measurement Management Systems)
• Strong knowledge in Metrology: traceability and measurement chain, chemical and physical standards maintenance, evaluation of measurement data (GUM / BIPM, Eurachem Guide.)
• Strong ability with written protocols and technical/ GLP/GMP documents.
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Work Experience.
Nuclear Electropower Generation, Plant Atucha I & II. NA-SA. Buenos Aires, Argentina. 2008-2013.
Quality Division Supervisor – Chemistry and Process Department.
• Development and implementing protocols for quality assurance for chemical and radiochemical measurements.
• WANO 2009 PEER REVIEW (Third – part audit) recommends the assurance program as a model for best practices at nuclear plant’s laboratories.
• Training and coaching in the identification and correction measurements.
• Maintaining and calibrating of measuring equipments and instruments on laboratory: pHmeters, mass balances, spectrometers, conductimeters, titration, volumetric and dosimeter instruments.
• Performing control and analytical controls: water treatment plant, impurities (metals and ions in ppb range), gas oils and derivates, radiochemistry controls in biological matrixes. Zinc addition to the primary system and cleaning chemical vapor generators.
JS Medicina Electrónica SRL. Medical Devices. Buenos Aires, Argentina. 2007-2008. Assurance Regulatory Responsibly.
• Maintaining GMP and GLP protocols in Reactive Diagnostic Plant and Medical Device Plant.
• Harmonization of Good Manufacturing Practice Guidelines to ISO 13485:2003 (Medical Devices) and CE...
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