CV, Curriculum Vitae and Online Resumes Search

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Online Resumes with "fda "

Engineering Technician

Qualifications: Mr. Stafford has acquired several years of experience in a vast array of electronic, electrical, chemical and mechanical disciplines. His experience includes, but is not limited to: Quality Inspector, Weld Inspector, Electronics Technician, Electronic Counter Measures Technician, Supervisor, Site Supervisor, Human Engineering, Application Engineering, and Information Management Officer. A Wisconsin State lic...

Tags for this Online Resume: Engineering, Amazon Web Services, Amplifier, Cabling, Cardiopulmonary resuscitation (CPR), Computer Operations, Control Systems, Corrective Actions, Distribution, Electronic Warfare

Assistant Director

Accomplishments Successful cost reducing negotiations with international, national, and regional vendors to include 8% cost reduction with UPS, 12% cost reduction with FedEx, 20% cost reduction with Verizon, 10% cost reduction with Panalpina, 10% cost reductions with The Scale People, Kenworth, and Webex. Implemented a successful Quality Assurance Department by establishing scheduled quarterly meetings, project and task tra...

Tags for this Online Resume: Distribution, Training, Audit, Complaints, Quality Assurance, Test, Fabrication, Metrics, Insurance, Management

Clinical Research - 0 Years of Experience

Good expertise in clinical trials and GCP ICH and FDA regulations * Ability to anticipate problems relating to projects and to develop and implement solutions Skilled with PC applications Microsoft Office Excel Outlook Oracle including patient and study databases and spreadsheets * Manage multiple projects at varying stages of completion * Effective in setting and meeting personal short- and long-term goals to complete assi...

Tags for this Online Resume: Data Analysis, ADA, Ada Programming Language, Audit, Inventory, Medical, Medical Records, Oncology, Oracle, Pathology, clinical, phase i, phase ii, clinical trials, phase iii, cro, pharmaceutical, regulatory, research

Not Listed

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

Tags for this Online Resume: Test, Documentation, Pharmaceutical, Customer Service, Lotus, Lotus Notes, Medical, PeopleSoft, Applications, Billing

Programmer Analyst

SUMMARY * 6 years of experience as a Statistical Programmer in Clinical trials of Pharma Industry. * Expertise in SAS programming features like BASE SAS, SAS/MACROS, SAS/STAT, SAS/GRAPH, SAS/SQL, and ODS. * Skilled in generating reports featuring various SAS procedures, like Proc Report, Proc Summary, Proc Freq, Proc Mean, Proc Transpose, Proc sort, Proc Univariate, Proc Datasets, Proc Compare, Prco SGPLOT, and Proc SQL. * ...

Tags for this Online Resume: Base SAS, Macro (Predefined Code), Proc, SAS, SAS/STAT, Statistical Analysis, Structured Query Language, Data Analysis, HyperText Markup Language, Microsoft Excel

Chemist - 8 Years of Experience - Near 08855

SUMMARY: * Over 16yrs pharmaceutical experience in Quality Control, Stability and R&D, Drug development & approval, sterile injectable pharmaceutical manufacturing, solid dosage manufacturing, aseptic techniques, and clinical packaging/ labeling for top pharmaceutical companies. * Solid background in Instrumental Analysis and GMP compliance. Expertise in hands-on use of instrumentation such ICP, GC/MS, HPLC, LC/MS, UV, and ...

Tags for this Online Resume: High Performance Liquid Chromatography (HPLC), Research, SEC, Securities and Exchange Commission (SEC), Support, Instrumentation, Audit, Good Laboratory Practices, Good Manufacturing Practices, oncology, phase, protocol, pharmaceutical, clinical

Compliance Manager

Professional Summary Competent, innovative, and forward-thinking management professional with extensive experience in advanced technology manufacturing environments and a proven track record of sustaining productive, high quality and cost-conscious production operations for mid-size and major corporations. Recognized for a thorough understanding of all processes, methods, procedures, equipment and materials used in high-tec...

Tags for this Online Resume: ANSI, Ansi (Am Natl Stds Inst), Audit, Compliance, Data Entry, Enterprise Software, ESS, Failure Analysis, ISO, Microsoft

Medical Equipment Repairer

SUMMARY OF EXPERIENCE * Technical knowledge and service skills to refurbish surgical lasers and radiographic systems to insure compliance with FDA guidelines. In depth experience related to: Gas Chromatography, x-ray Digital Radiographic and fluoroscopic systems. Cardiac Cath Labs, CAT Scan equipment, Laser Cameras, Electron Beam Recorders and Document Imaging Systems. Successfully resolved client technical issues via. tele...

Tags for this Online Resume: Security, Support, Technical Support, Sales, Applications, CT, Install, Lasers, Radiology, Customer Service

Biologist

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...

Ideal Companies: Jansen, Amgen, Bristol Meyers Squibb, GSK, Johnson & Johnson, Pfizer, Baush & Lomb, Mylan

Tags for this Online Resume: Management, HYGIENE, Audit, Complaints, Documentation, Corrective Actions, Engineering, Microbiology, Packaging, Policies and Procedures

Biomedical Engineer

Execution of entrepreneurial strategies with product manager discipline * Complete product lifecycle experience including requirements engineering support and marketing Blending engineering business and clinical resources * Design of edge analytics for IoT enabled services * Service modeling and development relating to personalized health and risk stratification Five successful product releases (multiple FDA submissions) * ...

Tags for this Online Resume: Technical Lead

Program Manager

ACCOMPLISHMENTS Seven years Medical Device Experience * Led team for 510K FDA approval on a medical robotic stent delivery system * Launched Digital Signal Processor medical device, met medical device quality requirements, built strategic alliances, achieved 510K FDA approval, and improved market share 25% * Cut development time by 50%, coordinated groups in 3 countries for design reviews, developed parallel activity with c...

Tags for this Online Resume: Reviews, Risk Management, EMC, Management, Program Management, Risk Assessment, Macromedia Flash, Product Launch, Program Manager, Quality

Quality Assurance Manager / Vendor Manager - 20 Years of Experience - Near 60060

SUMMARY: Experienced, dedicated, Quality Assurance professional and trainer who provides the knowledge and skills to assist with and drive projects as part of a team or as an individual contributor. * 20+ years of experience in pharmaceutical research, 15+ in Quality Assurance * Experience with Good Clinical Practice (GCP) regulations, the International Conference on Harmonization (ICH), Good Laboratory Practice (GLP), Vend...

Tags for this Online Resume: Quality Assurance, Test, Clinical Research, Research, Audit, Management, Pharmaceutical Industry, Development Activities, Policies and Procedures, Vendor Management, Clinical, GCP, GLP, Training, Nonclinical research, Preclinical, Early phase clinical research