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Online Resumes with "FDA"



Clinical Regional Monitoring - 10 Years of Experience - Near 20912

20/20, Addis Ababa University (CRO), Addis Ababa, Ethiopia, March 2005 to July 2006 Senior Clinical Research Associate - Opthalmology Studies, National Blindness, Low-Vision & Trachoma * Oversaw $3.5M study across 14 regional states to explore blindness, low-vision, and trachoma demonstrated sharp organizational skills in managing team of clinical data managers verifying data, and performing systematic networking of databas...

Tags for this Online Resume: Clinical Research, Research, Protocol, Collection, Critical Care - Neurology, Management, Neurology, Oncology, Quality, Quality Assurance

Vice President - 20 Years of Experience - Near 89134

An executive level position leading a Program Management Office, Business Process Optimization, Information Technology, Process Change and/or Manufacturing Ops that will integrate 25+ years of experience including strong Program & Project Management, Mergers & Acquisitions, Six Sigma, Supply Chain Integration and leadership skills with the analysis and usage of IT/IM solutions to enhance and improve new or existing processe...

Tags for this Online Resume: Management, Product Development, Program Management, Project Management, Reporting Tools, Budget Control, Budgeting, Integrate, AT&T, Data Management, Vice President, Senior Director, Portfolio Strategy Program

Clinical Pharmacovigilance/Drug Safety

SUMMARY * Health care professional with extensive years of experience with Pharmaceutical/Medical device industries as Medical coding and Pharmacovigilance professional in the processing and medical review/evaluation of reports related to investigational and marketed products in the following therapeutic areas: Oncology, Neurosciences, Cardiovascular, Pain/Inflammation, Rheumatology and Diagnostic products. * Responsible fo...

Tags for this Online Resume: Management, Process Improvement, Coding, Regulatory Reporting, Audit, Cardiology, Compliance, Metrics, Oncology, Data Entry

Pharmaceutical Quality Assurance - 8 Years of Experience - Near 43016

Tags for this Online Resume: Test, Documentation, Manufacturing, Pharmaceutical, Risk Assessment, Distribution, Scheduling, Clinical Research, High Performance Liquid Chromatography (HPLC), Microsoft Access, GMP, FDA Regulatory

Biomedical Engineer - 6 Years of Experience - Near 76248

Exposure clinical procedures Tech University Ruston, Louisiana * Design of an at home ear irrigation device that manage cerumen impaction * Worked with and Ear, Nose and Throat physician to develop product specifications and testing strategies * Integrated ISO standards, FDA regulations and CPT codes related to diseases state * Hands-on experience with patient diagnosis * Completes projects by assisting project team attendi...

Tags for this Online Resume: Biomedical Industry, Management, Manufacturing, Medical, Troubleshooting, Administrative Assistant, C++ Programming Language, Diagnostic Tools, Integrate, ISO, project manager, mechanical engineering

Biology - 20 Years of Experience - Near 30341

Summary of Qualifications Experienced and highly qualified Scientist & Research Associate/Manager with over 20 years of experience in researching and teaching. Highly proficient in performing quality assurance control on laboratory best practices while leveraging R&D experience to consistently achieve project goals. Adept at supervising other scientists and research technicians in advancing stem and primary cell industry kn...

Tags for this Online Resume: Compliance, Chef, Filing, ISO, Management, Legacy, Microbiological Testing, Product Development, Reliability, Test

Chemist - 13 Years of Experience - Near 07728

To obtain a challenging position in pharmaceutical industry involved in drug discovery and quality control that takes advantage of my experience in medicinal chemistry, organic synthesis and analytical laboratory skills. Willing to make an impact for the success and growth of a cutting edge company by utilizing my skills and experience. Professional Summary: * Experienced in medicinal chemistry, organic synthesis and qualit...

Tags for this Online Resume: Chemistry, Research, Sar

Biologist - 20 Years of Experience - Near 00727

Over 30 years experience in the Pharmaceutical Industry applying knowledge in GMP practices and FDA/European regulations at different areas such as Manufacturing Area Investigations Engineering Quality Compliance Quality Assurance Aseptic Area Manufacturing Training Safety Environmental Compliance and Purified Water Systems. Experience with solid dose aseptic filling and medical device processes investigations writing and e...

Tags for this Online Resume: HYGIENE, Audit, Complaints, Corrective Actions, Documentation, Policies and Procedures, Quality, Quality Assurance, Root Cause Analysis, CAPA, Process Investigations, Pharmaceutical Manufacturing, QA, QA Specialist, QA Reviewer, Microbiology, Purified Water Systems

Quality Assurance Specialist

Summary: Seventeen years' experience specializing in learning & development and technology related sales. The past 15+ years have been primarily focused in the pharmaceutical industry specializing in process improvement/performance consulting and employee development. As a facilitator of process improvement, one must understand the institutional context for which the improvement will take place. The ability to understand or...

Tags for this Online Resume: Consulting, LMS, Management, HCM, HR, Human Resources, Process Improvement, Project Management, Project Manager, Quality, curriculum, Orientation, automation

Production Tester - 20 Years of Experience - Near 75056

SUMMARY OF QUALIFICATIONS * Proficient in the operations of PC Demis * Certified by Mitutoyo for Video Coordinate Measuring System Operation and Programming * Certified by Zeiss CMM Operation in Programing with Calpyso Software * Proficient is the use of Sheffield CMM, Rockwell Hardness and Hardness Vickers * Proficient is Stereo Microscopes, Various Optical Comparators, Height Gages, and all hand held quality measuring dev...

Tags for this Online Resume: Pc, Personal Computer, CMM (Capability Maturity Model), Quality, Blue Prints, Compliance, Engineering, GD&T, Occupational Safety and Health Act, Orthopedic

CAD Engineer - 20 Years of Experience - Near 03223

SUMMARY OF QUALIFICATIONS * Extensive experience in various engineering positions effective at multi-tasking and working under pressure to accomplish overall objectives within a specific time period * Enjoy working with people and adapt easily to new situations and environments * Exemplary problem solving skills easily identify problems and implement corrective processes * Knowledge of OSHA, Ergonomic and CGMP Compliance an...

Tags for this Online Resume: Manufacturing, Project Management, Project Manager, Management, Pharmaceutical, Purchasing, Robotics, Applications, Layout, Manufacturing, Project Management, Applications, Pharmaceutical

Quality Manager - 20 Years of Experience - Near 37129

SUMMARY * Conduct medical device, cosmetic and pharmaceutical excipient and APIs, and supplier certification, evaluation and qualification activities, including on-site and desktop assessments of quality systems, product and process controls develop control plans for monitoring supplier corrective actions for quality, performance and delivery, employing standard industry tools (pFMEA, root cause investigation, lifecycle man...

Tags for this Online Resume: Instrumentation, Diagnostics, ISO, ISO 9001, Management, Document Management, Software, Assessments, Engineering