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Online Resumes with "FDA GMP"
SUMMARY Career highlights include building and directing a QA/QC function, Analysis, Testing, SPC project, Internal auditor in PWB high tech industry and Rechargeable Batteries of new technology (10+ years), Testing/Diagnose network systems to board level (5+years) & managing Analytical Labs in Food industry and Water Supply Sources (10+ years). Influenced on key committees and entrusted to manage the most confidential and ...
Tags for this Online Resume: Experience Auditor, Management experience, QA/QC profesional, Internal audit teamplayer, Microsoft Access profesional, Cisco system testing, Data Analysis Expert, Microsoft Excel professional, Microsoft Office profesional, NCR
Summary of Career Milestones: * BS degree in Industrial Technology. Final semester of a combined Masters Program * 25 years in various manufacturing environments including electro-mechanical, medical devices and Aerospace/Defense * Lean Six Sigma Master Black Belt Certified (LSSMBB) (Global Cert - Germany and Villanova University) * Multiple Quality related certifications from ASQ, ASNT, RAB, IRCA, SME. * Certified Internat...
SUMMARY Senior Quality and Regulatory professional experienced in high tech and medical device manufacturing industries. Progressive responsibilities in all areas of Quality Systems in the implementation of TQM, SPC, Six- Sigma, re-engineering, Continuous Improvement, Quality function deployment, implementation of FDA-GMP or QSR, ISO-9001, EN-46001, ISO 13485, EC Directives for CE marking on products, Clinical trial and Pro...
Areas of Expertise: * Project Management * Continuous Improvement (LSS) * Business & Quality Process Analysis * Industrial Engineering Methodology * Quality Engineering Management * Quality/Continuous Improvement Trng. * Health, Safety and Environment Quality Management and Auditing * Manufacturing and Testing Process * Supplier Development & Management * Strategic Planning * Supply Chain Management * Budget reporting * Gov...
Tags for this Online Resume: Quality, Quality Assurance, Welding, ISO, ISO 9000, Supply Chain, Consulting, Management, API, Application Program Interface, Quality Control, Lean Six SIgma, Quality Assurance, manufacturing, production, "project management"
SUMMARY: Over fifteen years of Research & Development and manufacturing management experience in Biotechnology/In-vitro Diagnostics industry. Broad experience in Research and Development and Manufacturing. HANDS ON EXPERTISE: * Immunochemistry Assay Development for Lateral flow and Microfluidic, Wet Chemistry. * Molecular biology assay development, amplification techniques including PCR & RT-PCR. * Pharmacokinetics and Immu...
Tags for this Online Resume: Research, Research and Development, Diagnostics, Toxicology, Support, Technical Support, Management, Chemistry, Data Analysis, High Performance Liquid Chromatography (HPLC), research, cro
QUALIFICATIONS & SKILLS * Experienced Operational Excellence Executive with a comprehensive Continuous Improvement skill set in Business Operations, P&L, Management and Manufacturing/Production * Specializes in driving operational performance improvement initiatives including turnarounds * Expertise in KAIZEN events, LEAN Manufacturing and waste elimination * Lean Six Sigma Black Belt Certified with 20+ years in an Operatio...
ACCOMPLISHMENTS * Lead the development of numerous market-leading dental alloys, porcelains and composites, including the world's bestselling dental porcelain system with $17M annual sales * Coordinated the development and successful clearance of multiple Class II medical device 510 (k) s. * Developed multiple product validation and verification plans as per Global Innovation Process (GIP) requirements in compliance with IS...
Tags for this Online Resume: nanotechnology, composite materials, alloys, advanced materials, medical device, aerospace, automotive, metallurgy, dental, project leader, project manager, timeline, project planning, 510k, FDA, BSI, cGMP, Troubleshooting, Field Testing, metal matrix composites, ISO testing
Career Summary Quality control and method development for nutrition products. * Project management for government /military funded projects as well as collaboration with sporting goods and chemical industries for prototype product development and marketing technical support. Multi-tasks management, coordinate cross-functional activities between groups and related sub-contractors within project timeline and budgets. * Proto-...
Tags for this Online Resume: Resource Scheduling, Scheduling, Test, Troubleshooting, Budgeting, Clinical Research, Marketing Management, Product Launch, Project Management, Project Manager, pharmaceutical, Sr. Analytical Chemist
SUMMARY: Extensive experience in documentation, both writing and electronic documentation systems in the medical device/pharmaceutical industry. Experience in multiple training systems. Looking for employment using the skills listed below:: * Documentation Systems Technical Writing Compliance (FDA, GMP) Customer Complaint Handling * EDMS Training Communication ISO 9000