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Austin, Texas Area United States

Quality through innovative solutions

Medical / Health Care / Pharmaceuticals

I have worked in the area of quality in the field Biotechnology since 1994. My responsibilities have included development of QC assays, inspect incoming and in process materials, address customer complaints, administer control of nonconforming materials, document control, validation review board, corrective/preventive action, internal audits (ISO 13485). I was part of the core quality team responsible for developing and implementing our ISO 13485-compliant quality system, which passed a registration audit in 2005. I was the program manager for implementation of the ISO 13485-compliant quality system for microarray manufacturing at Agilent Santa Clara. I was the quality and compliance ...