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Manager Test Cases

Washington, DC
... ● Tested application with FDA regulations for software validation, 21 CFR Part 11, and G(X) P. ● Updated and maintained Software Compliance SOP’s. ● Conducted Facility inspections and Method audits according to schedule ● Managed defects with QC ● ... - 2017 Jul 05

Test Cases

Reston, VA
... Developed and tested FDA compliance requirements pertaining to CFR 21 part 11 with regards to electronics signature. Maintained Requirement Traceability Matrices to measure the testing progress Interfaced with developers in resolving the defects ... - 2017 Jun 27

Medical Technical Support

Falls Church, VA
... PLM knowledge, multi task handling ability with the knowledge of EU Medical Device Regulations in compliance with relevant standards like: ISO13485, 93/42/EEC Life Sciences: US FDA regulations 21 CFR Part 11 (210/211, 150, 56, 58, 311, 314, 820), ... - 2017 Jun 27

Customer Service Manager

Washington, DC
... Green Leadership Scholarship, 2013, 2015 College of Undergraduate Studies, Featured Author, October 2014 College of Undergraduate Studies, Public Service, Published, March 2015 MedStar Certified, FDA Research Coordinator, 2013 MedStar Centricity EMR ... - 2017 Jun 26

Engineer Computer Science

Reston, VA
... Analyze FDA data center migration proposal and requirements. Design, Review and Validating new data center software architecture. Research new technology compatibilities. Working with development team to migrate, configure and debugging legacy ... - 2017 Jun 21

Professional Experience Medical

Derwood, MD, 20855
... preparation Medical Information Collaboration with Marketing Initiatives CMC documents including stability reports and assay validation Authored FDA briefing documents for meetings PROFESSIONAL EXPERIENCE Consultant/Contractor BioPharm Global, Inc. ... - 2017 May 31

Interpreter Training

Fairfax, VA, 22030
... Assistance Committee projects, US Congress 2007, 2008, 2009, 2010, 2012 Interpreter for Food and Drug Administration (FDA) inspection in Indonesia, August 2009 Simultaneous interpreter for Rule of Law program for Indonesian law enforcement ... - 2017 May 24

Integration solution architect

Reston, VA
... It involves integration with Salesforce, 3rd party legacy systems, SAP, FDA, master data hubs etc. Integrating systems Salesforce, Lionbridge (Language Translation), FDA Electronic Submission gateway, SAP, Product and Customer data hubs Solution ... - 2017 May 17

Project Management Quality Assurance

Fairfax, VA
... 2003 Food and Drug Administration (FDA) ● Subject Matter Expert for analysis of software systems development process at an Agency level. ● Designed agency-wide System Development Life-Cycle (SDLC) compliant with OMB 300 requirements and in ... - 2017 May 15

Management Manager

Washington, DC
... Food & Drug Administration White Oak, MD Records Management Subject Matter Expert Supported the development and establishment of a clear and unified direction for FDA Records Management Program• Address targeted needs for electronically stored ... - 2017 May 04
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