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Online Resumes with "21 CFR Part 11"



Computer Programmer - 20 Years of Experience - Near 33156

Hi, I wrote the BEST GUI for Angular 2 Mobile App Frame called SwipeClouds that is SUPERIOR to Ionic Read My Article About It: https://www.codeproject.com/Articles/1175045/Angular-Mobile-App-with-JQuery-Mobile-Cordova-or-P Previously I developed software for Microsoft as their Director of Live Search Marketing & Software Development. And at MySpace.com I was their Director of Software Development. I work with the lates...

Tags for this Online Resume: jQuery, Microsoft, Microsoft Windows, Blackberry, Hyper Text Markup Language 5, Marketing Management, Project Leader, Video, Security, Software, linux, it jobs, c++, html, agile, c#, software, javascript, java, sql, PhoneGap, HTML5, Angular, Angular4, Angular2, Angular 5, JQuery, Mobile, Java, Objective C, SwipeClouds Framework, Canvas, CTO, Director, .NET, VB .NET, Angular 1.4, React

Quality Assurance Specialist - 7 Years of Experience - Near 75093

Professional SUMMARY * Over all 7 years of experience in the IT industry in Quality Assurance using Web based and Client/Server applications. * Knowledge of Healthcare, Pharma, Security and Biometric projects. * Key expertise includes testing Extensive experience in Manual and Automated testing using Selenium and defect tracking tools like HP Quality Center (ALM/QC), Bugzilla, JIRA and Bug Zero. * Conversant with all phases...

Tags for this Online Resume: Management, Oracle, Regression Testing, System Testing, Test, Software, JIRA, Microsoft, Microsoft ASP.Net, Microsoft SQL Server

validation/quality/manufacturing engineer

PROFESSIONAL SUMMARY: * Experienced as validation engineer and experience in Process Validation, and Test Method Validation in compliance with FDA standards * Expertise in writing Test method Validation Protocols (TMV-P) and executing the protocols * Experienced in validating different types of test methods (Attribute Test Method, Variable Destructive Test Method, Variable Non-Destructive Test Method, Analytical Test Method...

Tags for this Online Resume: Reviews, Root Cause Analysis, Test, Assessments, Documentation, PFMEA, R&R Report Writer, Regulatory Affairs, Reliability, Risk Assessment, manufacturing

Statistical Programmer - 5 years Experience - US

Summary * Certified Base Programmer for SAS 9 with 5+ years of biostatistical programming experience in CRO, hospitals, pharmaceutical, and healthcare industries. * Involved in drug development process with experience in analyzing, reporting, and reviewing pre-clinical/clinical trial data. * Good understanding of FDA submission (IND, NDA) process, clinical protocols, CRFs, CDISC (SDTM, ADaM), 21 CFR Part 11, GCP, and IRB gu...

Tags for this Online Resume: SAS, Proc, Programming, Statistical Analysis, SAP, Research, Statistics, Structured Query Language, Management, Test

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

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

Network Engineer - 13 Years of Experience - Near 23188

Experienced with MSP applications such as Connect Wise and Kaseya providing comprehensive IT support to small and medium size businesses. * Palantir. O365 Migration Consultant, Palo Alto, CA 4/17 - 7/17 Created documentation to minimize foreseeing users' migration disruptions. Ei, Distribution list, Rooms, Transport Rules etc Worked with Power shell to create Bulk users, Distribution lists, O365 Groups, and place mailboxes ...

Tags for this Online Resume: Active Directory, Applications, Blackberry, CFR Part 11, Cisco, Cisco Switches, Database, Database Applications, Dell, Desk Top Support, Netwrok Engineer

Business Analyst

Qualifications Summary * Over Twenty years' technical writing experience in an enterprise delivery setting. Expertise with end-to-end SDLC/ITIL software development process industries I've worked in include: Electric Utilities, Financial Services, Mining, Food and Beverage, Food and Produce Distribution, Health Imaging, Manufacturing, Oil and Gas, Pharmaceutical IT, Retail and Media Relations * Develop both classroom and we...

Tags for this Online Resume: Documentation, Lightweight Directory Access Protocol, Research, Research and Development, Risk Analysis, Script, Technical Documentation, Test, Test Script, Technical Writing

Physician - 20 Years of Experience - Near 55347

SUMMARY MEDICAL AFFAIRS and clinical research programs in Pharmaceutical and medical devices companies * Clinical Research Associate and Manager in several Phases III and IV Clinical Trials in a Pharmaceuticals, Biotechnological and Medical Devices companies: * Coordinator of study logistics, Trial Master File management, IRB/IEC submission, drug shipments, enrollment and safety, maintaining and ensuring all documentation a...

Tags for this Online Resume: Clinical Research, Research, Consulting, Regulatory Affairs, Hepatitis, Medical, Training, Cardiovascular, Compliance, Management

Project Manager - 20 Years of Experience - Near 60124

Skills Summary A Senior Software Professional who has exceptional project management, client relationship and leadership skills with a proven track record of managing multiple projects with multiple stakeholders and multi-disciplinary teams delivering projects on time, on budget and to the client's satisfaction. * A certified PMP having 20+ years of Software Engineering experience that includes: * Project Management and Sta...

Tags for this Online Resume: Project Management, Project Manager, Management, Oncology, ISO, Pharmaceutical, CFR Part 11, Documentation, Change Management, Insurance

Clinical Regional Monitoring - 21 Years of Experience - Near 60031

Over 15 years experience in Clinical Research and Regulatory Study Protocol specifics - ICF's, Inclusion/ Exclusion Criteria, AE/SAE, eCRF's, and SOP Development/Updates * Exceptional attention to detail with strong problem solving skills * Excellent written, verbal and decision making skills * Outstanding interpersonal communication, organization and prioritization skills * Proficient with GCP, ICH guidelines, FDA regulat...

Tags for this Online Resume: Program Manager, Collection, Accenture FOUNDATION, Accounts Payable, Attention to Detail, Billing, Biomedical Industry, Budgeting, Clinical Research, Data Mining