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Online Resumes with "Part 820"



Quality Coordinator - 5 Years of Experience - Near 08817

PROFESSIONAL PROFILE SUMMARY * A Quality professional with over twenty years' experience in Pharmaceutical and Biotechnology industries. Expertise in pharmaceutical, biological and aseptic manufacturing of sterile injectable and non sterile drug products with an emphasis on regulatory compliance including deviation review (laboratory and production), FDA inspection readiness, quality systems and cGMP compliance. Implemented...

Tags for this Online Resume: Management, Compliance, Reviews, Pharmaceutical, Audit, Documentation, Quality Assurance, Test, Manufacturing, manufacturing, production, reliability, mechanical engineer, electrical engineer, machine operator, maintenance, die cutting

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Clinical Regulatory Affairs - 20 Years of Experience - Near 80023

SUMMARY OF PROFESSIONAL EXPERIENCE Regulatory, Quality, Clinical and Compliance Medical Executive with major milestones/achievements in the Life Science Industry. Over 30 years in Class III and Class II devices/allograft/biologics, inside/outside the United States (OUS) primarily in the fields of cardiology, cardiovascular, neurology, spine and orthopedics. Integral involvement with 80+ product categories. Personally prepar...

Tags for this Online Resume: Medical Device, Regulatory/Quality, Clinical, Audit, Distribution, Budgeting, Microsoft Windows CE, Advertising, Cardiovascular, Compliance, clinical, trial, protocol, ich, FIM, EFS, gcp

Quality Assurance Director - 0 Years of Experience

Engineering professional with in depth work experience in lean manufacturing, process engineering, research and development, quality assurance, Quality System programs including CAPA, Audits, Supplier Quality, RiskManagement, Complaint Investigations and Document Control. * Experience in root cause analysis, developed testing strategies to support test executions, process verification/ validation, Assembly line, Current/new...

Tags for this Online Resume: Manufacturing, Product Development, Reliability, Root Cause Analysis, Statistical Analysis, Assessments, Compliance, Documentation, Engineering, Evaluate

Medical or Health Services Manager

Tags for this Online Resume: Chemistry, Management, High Performance Liquid Chromatography (HPLC), Scheduling, Documentation, Services, Test, Electrophoresis, HP, Microsoft Excel