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Online Resumes with "FDA Regulation"
Engineering Technician
Tags for this Online Resume: Metal coating, vacuum technologies, DAC, Lathes, Packaging, Software, Manufacturing, Support, White Papers, Apple Mac OS X, Apple MacIntosh Operating System, MCSA, Wireshark, Color management, Fiery pro certified
Clinical Research - 1 Years of Experience - Near 35806
Professional Summary: Dynamic Clinical Research Scientist with five years of international research experience. Demonstrated expertise performing research feasibility, data collection and analysis, investigative procedures verification and report preparation. Proven medical knowledge of cardiology, nephrology, emergency medicine, intensive care, endocrinology, and gastroenterology. Skilled at researching diabetes and metabo...
Tags for this Online Resume: Clinical Research • Data Management • Statistics • Drug Safety • Clinical Study Reports • Diabetics Interventions Budget Management • Clinical Operations • Regulatory Submission Documents • Protocol Preparation • QA / QC Clinical Study R, GCP, FDA, TPD Regulations FDA Regulations • Clinical Trial Monitoring • Nutritional Biochemistry • Diet / Exercise • Metabolic Disorders, Research, Monitoring, Benefits, Cancer, Clinical Research, Insulin, clinical, oncology, pharmaceutical, gcp
Clinical Quality Assurance - 20 Years of Experience - Near 27709
Tags for this Online Resume: Quality, Validation, Chemist, Scientist, FDA Regulation, Data Review
Developer - 7 Years of Experience
PROFESSIONAL SUMMARY * Over 9 years of Clinical SAS programming experience in a Pharmaceutical industry involving different Phases (I, II & III) of clinical trials. * Experienced in working closely with statisticians to provide SAS programming in analyzing clinical trials data and generating Statistical Analysis Files, Tables, Listings, Summaries and Graphs/Figures (TLFs) for the Integrated Summary of Safety (ISS) and Integ...
Tags for this Online Resume: Microsoft Windows, SAS, Structured Query Language, Unix, Microsoft Windows 7, Windows 7, PDF, Proc, Extensible Markup Language (XML), Microsoft Excel
Biomedical Engineer - 2 Years of Experience - Dallas
SUMMARY: Biomedical Engineering graduate student with a specialization on Medical Imaging and Instrumentation. Hands on experience in operating complex medical equipment and expertise in image processing. IISE Certified Six Sigma Green Belt. Knowledge of ISO 14971, ISO 13485 and FDA regulations. Independent researcher, Dedicated, Self-Driven, Self-Motivated, Result Oriented, Team Player, Detail Oriented, and a Quick Learner.
Tags for this Online Resume: Data Analysis, Matlab, Biomedical Industry, C Programming Language, C++ Programming Language, Connectivity, Engineering, Green Belt, Image Processing, Imaging
Operations Manager - 16 Years of Experience - Near 10032
Managed Managed the logistics and traffic operations for the liquid sugar, bulk sugar, and sugar mixing operations in three warehouses- two in cost effectiveness and control efficient production procedures and compliance with standard food safety procedures the three warehouses. * Monitored inventory levels in the three locations to ensure efficient production shipping and customer fulfillment - always exceeding customer ex...
Tags for this Online Resume: Audit, Documentation, Settlements, sheets, Transportation, Vendor Invoices, Vista, Commercial Loans, Logistics, Supply Chain
Chemist - 13 Years of Experience
SUMMARY OF QUALIFICATIONS: * Strong organizational and technical skills, highly efficient a quick learner. * 13+ Years of experience with Analytical Testing within GMP environment. * Understands and complies to ICH guidelines, cGMP, GLP, and FDA regulations. * Very enthusiastic and motivated in learning new instrumentation and methods. * Work effectively under high pressure environment and never compromise with ethics and q...
Tags for this Online Resume: Quality, Quality Assurance, High Performance Liquid Chromatography (HPLC), Documentation, Instrumentation, Software, Test, Troubleshooting, 5S, Documentum
Project Manager
A position that can leverage my experience managing large, complex IT environments that require adherence to process while building excellent customer partnerships and strong internal teams. - Project Design and Management - IT Infrastructure Deployment - Issue Management and Mitigation - Proactive Client Relationships - Large IT Project Deployment - Budget Creation and Management - Process Creation and Documentation - Chan...
Tags for this Online Resume: Data Center Services, Services, Itil, Project Management, Project Manager, Customer Relationship Management, Documentation, Infrastructure, Inside Sales, Professional Services
Business Analyst - 7 Years of Experience - Near 08817
Professional Summary: * 10+ years of overall IT experience with 6+ years of Business Analyst / Project Coordination and management expertise in Healthcare and Pharmaceutical Industry. * Lead JAD sessions to aid in requirement gathering, prototyping and documentation of business and system needs via BRDs, FRDs User Stories, Use Cases, Workflows, Wireframes and Software Requirement Specifications. * Expertise in implementing ...
Tags for this Online Resume: Business Analysis, Business Analyst, Information Technology, Acceptance Testing, Active Server Pages, Adobe, Adobe Acrobat, Agile, ANSI, Ansi (Am Natl Stds Inst), PMP certified, VISIO,MS Project
Clinical Regulatory Affairs
Over 25 years of experience in Drug Regulatory Affairs pharmaceutical development and registration with a thorough working knowledge of FDA regulations and requirements related the pharmaceutical industry emphasis on Chemistry Manufacturing and
Tags for this Online Resume: Gateway, Project Leader, Spl (HP-Sys Asmblr Lang), Regulatory Affairs, Integrate, Assessments, Integrated Development Environments, Microsoft Word, Word Processing, Manufacturing
Medical Scientist - 13 Years of Experience - Near 21136
HIGHLIGHTS OF QUALIFICATIONS: * 2+ years of clinical research monitoring experience and 25+ years pre-clinical experience * Knowledge of clinical trial procedures and approval processes. * In-depth knowledge of ICH GCP guidelines * Knowledge of FDA regulations * Knowledge of clinical trials for investigative biomedical and pharmaceutical studies. * Good working knowledge of Pharmacology, Epidemiology, Biology, Chemistry, Ph...
Tags for this Online Resume: Cancer, Leadership, Medical, Patient Care, Quality, Quality Assurance, Quality Control, Trauma, Troubleshooting, Phlebotomy
