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Were you looking for FDA-Guidelines job results?
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Online Resumes with "FDA Guidelines"
Chemical Engineer
PROFILE project management and handling instruments/equipment * Good understanding of various chemical processes (Distillation, Heat Transfer, Fluid Mechanics, Chemical Reaction Kinetics) * Excellent knowledge in ISO Standards, FDA guidelines 21 CFR Part 11, Part 210, Part 211, SOP, cGMP, cGLP, Audit trails, GAP Analysis * Familiar with safety protocols followed in research labs and worked on projects/assignments related to...
Tags for this Online Resume: Statistical Analysis, Audit, Autocad, Autodesk AutoCAD, C Programming Language, CFR Part 11, Corrective Actions, Green Belt, HAZOP, HTTPs
Camera Operator
Summary º Skilled professional with many years of knowledge and expertise in Quality Control and Analytical Development arena with a demonstrated record of implementing and maintaining quality systems º Extensive experience in analytical method development, method validation and method transfer for APIs, Solid / Liquid Oral Dosage Forms, and Injectables º More than six years of experience at Manager/Supervisory level º Well...
Tags for this Online Resume: Audit, Research and Development, Quality, Quality Assurance, Quality Control, Test, Corrective Actions, Utilities, Services, Troubleshooting
Production Supervisor - 20 Years of Experience - Near 60538
Summary Manage with production and distribution experience. Excellent communication and organizational skills: Ability to adapt to and solve unanticipated occurrences and minimize the impact on production: desire to motivating staff to meet industry demands in a high-volume environment Optimum Nutrition Mar. 2010 - Present Shift Production Supervisor Held daily pass down meetings, reviewed daily job orders, prioritized hot ...
Tags for this Online Resume: Audit, Bilingual, Cardiopulmonary resuscitation (CPR), Distribution, Enterprise Requirements Planning, Forklift, Inventory, Kronos, Kronos (Labor Mgmt Sys), Management
Life Scientist - 20 Years of Experience - Near 20721
Summary * Project Officer and Work Assignment Manager human health toxicologist in the in the U.S. Environmental Protection Agency's (USEPA) Office of Water (OW) to support agency products registration and other regulatory activities * Developed human health benchmarks for registration/regulation of drinking water and environmental contaminants for the USEPA * Developed multivariate computational toxicology in silico QSAR m...
Tags for this Online Resume: Risk Assessment, Management, Toxicology, Integrate, biologist, toxicologists, Assessments, Cancer, Data Analysis, Database, ESA
Clinical Regulatory Affairs - 6 Years of Experience - Near 92648
QUALIFICATIONS Document-Labeling Specialist, Nov.2015 - Feb.2016 Well-versed communicator, high organizational and analytical (Contract Position Only) abilities. Work well independently and as a member of a * Creation, Revision of CGL, pre-printed labels and IFU via team. Adept in SUSARs, IRB submissions, Sponsor redlining documents and SOP standards. monitoring, and CTMS files. Efficient at handling multiple regulatory doc...
Tags for this Online Resume: R programming, Word, Excel, Adobe Photoshop, Illustrator, google analytics, github, Adobe, Data Entry, Documentation, ISO
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
Clinical Research - 20 Years of Experience - Near 32828
My career objective is to become a part of your Organization and to apply my experience and knowledge during the conduct of clinical trials, with emphasis on safety, efficacy in accordance to ICH-GCP, FDA and study protocol guidelines. Further, I will always strive to accomplish efficiency and savings for clients, by developing effective monitoring tools
Tags for this Online Resume: Microsoft-Office, ICH-GCP, FDA-guidelines, CTMS, EDC, RAVE, Monitoring, Clinical trials, Cardiovascular, Management, Auditing
Clinical Research
PROFESSIONAL SUMMARY: Experienced Clinical Research Professional seeking career advancement with a CRO where I can make a positive contribution by utilizing my clinical research expertise. In-depth knowledge of clinical trial policies and procedures, study protocols, GCP guidelines, ICH guidelines, regulatory clinical trial documentation requirements, IRB documents submittal, sponsor electronic data capture systems for data...
Tags for this Online Resume: Chemotherapy, Clinical Research, Collection, Gastrointestinal, Oncology, PEDIATRIC, Protocol, Support
Admissions Director - 0 Years of Experience
SUMMARY * Pharmacovigilance Associate with over 2+ years of experience in Drug Safety and Clinical practice fields with clear understanding of EDC (Electronic Data Capture) * Experience in performing successful data management, triage, case entry, MedDRA, WHOdrug dictionaries, narrative writing, peer review, case follow-up, case review and report preparation * Performing Data entry and Quality check adverse event reports fr...
Tags for this Online Resume: Quality, General Practice, HYGIENE, Medical, Surgical, Acceptance Testing, Assessments, Business Intelligence, Coding, Database, healthcare
Medical Scientist
Areas of Expertise PK Data Analysis & Software * Bio-analytical Techniques * Clinical Trial Management * PK/PD Modeling FDA Guidelines & Regulatory Compliance * PK/PD Studies & Models * Pharmaceutical Research Clinical Presentations * Stakeholder Relations * Product Data Knowledge * Scientific Platforms* In Vivo & In Vitro Absorption Models * Communicating Complex Scientific Education * Statistical Analysis & Modeling Simul...
Tags for this Online Resume: Derivatives, Software, Chemistry, Pharmaceutical Industry, Cancer, Dermatology, Electrical Stimulation, Pharmacology, Pharmaceutical, Clinical Research
