Professional IT Senior manager/specialist with Quality Assurance, Compliance and Project Management experience. A diverse background in the Pharmaceutical, Labs, Research Development and Telecom industries. Well versed in FDA Part 11 Compliance, Auditing, Quality Assurance Management, QA Project Management, QA analysis, IT Quality Processes, SDLC and Standard Operating Procedures. A strong knowledge of all aspects of the System Development Life Cycle with an in depth knowledge of quality assurance methodologies, which include manual and automated testing ensuring application and system quality, reliability and fulfillment of business requirements. Excellent communication, interpersonal and analytical skills developed throughout many years in diverse organizations and projects working as both an engineer and a manager of technical resources for diverse systems, applications and interfaces.
- Digital media solutions company providing development and production for Web, Digital Apps, Music, Video and Photography projects.
- Digital media solutions specializing in Web Design and testing, apps, music, video and photography.
- Web design and functionality testing WordPress platform . Site administration and hosting setup.
- WordPress Plugin testing and troubleshooting. Marketing of online digital solutions.
- iPhone app design, mockup and development.
- SEO Search Engine Optimization projects for businesses.
- Music production, composition, digital mastering and audio sweetening.
- Digital video production and editing. YouTube partner video productions.
- Digital Photography and editing. Commercial and journalistic photography projects.
- Managed and coordinated a team of 15 test engineers/developers performing Quality Assurance Testing for a suite of clinical trial and regulatory applications.
- Designed, developed and maintained a full test suite for multiple systems.
- Authored Computer System Validation documents
- Authored bug reports and track until closure, participated in change management committees.
- Hands on manual testing, black and grey box, ad-hoc, UI and UX
- Quick Test Pro and Quality Center test suite automation expertise.
- Testing of IVRS Interactive Voice Response Systems testing
- Performed Disaster Recovery, hot backup and failover testing
- Testing of ETMF Electronic Trial Master File SharePoint implementation
- Researched, evaluated, and provide recommendations for software purchases.
- Audited IT Operations and processes.
- Audited external vendor processes and documentation
- Knowledge of Pharmaceutical Clinical Trials, procedures and operations of EDC Electronic Data Capture
- Oracle Clinical and Clintrial CDMS interfacing.
- Well versed in FDA - 21 CFR Part 11 Electronic Records and Electronic Signatures Compliance
- Responsible for document review, approval of processes and management signoff.
- Review and approval of system documentation according to SOP processes and FDA policies.
- Review, updates and approval of SOPs during bi-annual reviews.
- Developed SOPs for new IT processes and policies.
- Ensure compliance of programs and projects to insure they follow quality policies procedures
- Manage internal and external client audits and represent IT Quality for sponsor audits.
- Develop, harmonize and enhance policies procedures from multiple organizations
Quality Assurance Manager
- Managed a team of six test engineers project managing all testing efforts and test cycles which included estimating timelines, team assessment, test strategy, test assignments, execution procedures, issue tracking and resolution and status reporting.
- Estimated System Testing Timelines, resources, planning/tracking and reporting to Director and Division Managers and peers.
- Performed detailed analysis of system requirement definitions, Maintenance and Change Requests with an emphasis on managing strategic functional end-to-end QA group testing efforts.
- Authored Testing Strategies and System Test Plans for release features. Compiled System Test scenarios and scripts for functional assurance testing.
- Performed Assessments of Automated Testing tools. Contacted outside vendors and evaluated tools for use with Siebel's eCRM product testing for regression, sanity checks and feature assurance. Provided recommendations to VP, Director, Division and District Levels.
- Project managed team efforts for full regression suite as well as all test processes and documentation.
- Lead Manager and Lead Quality Assurance Analyst of Transport Automation, FrameWorks, MNS Managed Network Services , AT T WorldNet Firewall, OOB/DBU CPE Out of Band/ Dial back-up and MRS Offer Assurance web features residing on the AT T Solutions GEMS Platform.
- Project Managed group of four to six engineers testing all aspects of MNS functional test cycles including estimating cycle timelines, resource planning, case assignments, execution procedures, test data control, bug investigations and MR maintenance request tracking and resolution.
- Performed detailed Analysis of system requirement definitions for testing applicability.
- Authored System Test Plans and Testing Strategies for release features.
- Authored System Test scenarios and scripts for feature functionality assurance in Integration, System Test and User Acceptance phases.
- Performed BIT, feature, functionality, web, interface, batch, regression, performance and user acceptance testing.
- Assured Quality of Production Deployment Procedures and installation guides.
- Re-Engineering and Analyst of Web based Support Center tools.
Skills Technical Information Skill Set
Quality Assurance Manager, Pharmaceutical EDC CDMS QA specialist, QA Analyst, QA Lead Engineer, QA Assessment, Planning, Tracking, and Project Management, Application Testing, Interface Testing, End-to-End Testing of Client/Server, Web Applications, Network Correlation, Security Testing, Microcomputers.
Grant Plan, Pharmaceutical EDC CDMS suite, Clintrial EDC CDMS, Oracle Clinical EDC CDMS, Mercury Interactive QTP Quick Test Pro , Mercury Interactive Quality Center Test Director, Mercury WinRunner, Microsoft VSS Visual SourceSafe 6.0, SnagIt, DBVisualizer, Siebel CRM Customer Relations Management , HP Open-Vue IT-O, NNM Network Node Manager , Cisco NetRanger MIDS , Windows NT, Windows 2000/NT/ME/XP, Exceed, Exchange/Outlook, IExplorer, Netscape Navigator, Apple Safari, HTML, MS-DOS, SUN OpenWindows, SQL, UNIX-OS, INFORMIX-SQL, Oracle Client, ProFTP, Remedy ARS, AutoTester, SQA-Robot, T Test Case Generator, BadBoy, Empirix e-Tester, STP Software Through Pictures , Framemaker, AmiPro, MSOffice, Visio Professional, AT T Sablime Software Code Control, Microsoft Office Word, Excel, Powerpoint, MS Project , FrontPage Website Design, Macromedia Dreameaver, Adobe Photoshop, SUN servers, SPARCS, Ultra , PCs, Apple OS9 through 10.x Panther, Digidesign Pro Tools, MOTU Digital Performer, Bias Peak Audio Editing, iMovie, Final Cut Pro, iDVD, DVD Studio Pro, iWeb, Keynote, WordPress.