Experienced Quality professional with strong validation background.
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Quality Assurance, Validation
My goal is to come into a company and improve efficiency and effectiveness of document controls systems to increase customer satisfaction, both internal and external.
Tags for this Online Resume:
Document Control, Configuration Management, Change Control, Internal Auditing, Quality Systems
• Currently stationed in Asia to manage major international suppliers in Japan, Korea, Taiwan, and Australia including Mitsubishi Heavy Industries, Ishikawajima-Harima Heavy Industries, Samsung Techwin, Aerospace Industrial Development Company, Kawasaki Heavy Industries, and more.
• Represented Pratt and Whitney to ensure that suppliers' quality system, processes and products met purchase contract requirements and applicab...
Quality Assurance professional with problem-solving abilities in Pharmaceutical and Biotechnology industries. Primary strengths include US (FDA) 21 CFR, and ICH Q7A Guidance for API Manufacture, Quality Systems development and implementation and strong auditing skills. Introduced and managed electronic document management software including validation, implementation, and maintenance, as well as project team leadership. R...
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Quality Assurance, FDA regulations, CAPA, Document Control, Change control
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CQM-OE ASQ Certified, FDA Regulated Industries, GMP, GLP, SOPs, HACCP Experience , Influencial Leader, Driven by goals, Motivated by results
My goal is to join an organization developing innovative products that change patient's lives. I strive to create and maintain quality teams and quality systems that support the company goals of producing products that exceed the customer expectations.
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CAPA, Validation, Lead auditor, New product development, ISO 13485, Combination products
Obtain a position where I can maximize my BSN, RN nursing, pharmaceutical research and management skills. Apply my knowledge of AE reporting, quality assurance, risk management, auditing, clinical trial studies, regulatory reporting, employee supervision and development, and training experience.
I am primarily interested in obtaining a VP position and using my knowledge to truly direct and enhance a companies experience with quality systems and to provide their customers with products that meet or exceed customer expectations.
Ideal Companies: Medical Device Manufacturers
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Quality Assurance, Project Management, Auditor, ISO 13485:2003, 21 CFR 820, QSR, Regulatory, Management, Medical Devices
To obtain a position where I can maximize my multilayer of management skills, quality assurance, program development, training experience, customer service, and a successful track record in the Blood Banking care environment.
Ideal Companies: schools, health, hospital, clubs
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•Acting Education Manager, American Red Cross, Oakland, CA: 2004 - 2008 •Education Coordinator, CA: 2003 - 2004 •Phlebotomist, CA: 2001- 2003 •Cable Television CATV Supervisor, Core Communication Inc, Sunnyvale, CA: 1998 - 2001 •CATV System Technician, TCI Cablevision Inc, Fremont, CA: 1991 - 1998 •Technician/Day Shift Supervisor, Avantek Inc, Milpitas, CA: 1984 - 1991 •Airport Security Supervisor, Wackenhut, San Jose, CA: 1983 - 1984 •Multi Craft Instructor, APO NY Germany: 1981 - 1983 •Communication Expert, US ARMY, APO NY Germany: 1979 - 1983
