PROFESSIONAL EXPERIENCE:

Confidential

Product Quality Assurance Engineer

• Wrote test scripts using manual/automated test type structure via MS Excel, HP ALM QC v11, Cucumber, Spinach Files and Git Lab/Bash.
• Design and Developed composite specs, revision specs, test plan, test cases, test execution, test report to support operations and service delivery team in production deployments. Review automated user scenarios against user requirements and ruby files (spinach files, cucumber).
• Perform testing activities towards SaaS as important deliverables for R&D.
• Integrated a Product QA agile manual/automated process to support eClinical OS for JIRA, Gherkins/Jenkins, Lean Kit, HP QTP v11.52 ALM.
• Design with Sr. Study QA and Sr. PQA to define testing requirements for software applications and products. eClinicalOS Study Designer with Inventory/Dispense Certified in compliance with SOP, cGxP, cGCP, cGLP, cGMP (21 CFR Part 11, Annex).
• Produces system documentation for the applications individuals work on (Document Control Repository and Change Control System) such as Confluence and JIRA.
• Use change control and ticket tool (JIRA, LeanKit, GIT, Source Tree).
• Supported EDC CIMS, ePRO, Randomization, Cohorts Dispense/Shipping, Endpoint Adjudication, Medical coding and Laboratory Normal.
• Adhere to the regulatory requirements, best practices of software development and provide accurate status reports on all activities as necessary.

Confidential

Data Manager

• Certified trained: NPD, SOPs (21 CFR Part 11, Annex 11), GOPs (cGxP, cGMP, cGLP, cGCP), Introduction to NPD, Regulatory Affairs, Quality Assurance, Animal Welfare, Clinical Safety & AEs and iMedNet (EDC) Designer Certification.
• Responsible for the creation, design, maintenance of eCRFs and database manipulations against 21 CFR 210,211.
• Used web design, PL/SQL, T - SQL, XML and Crystal Reports for Business Logics/Work Flows per user requirement.
• Performed edit checks (rules and derivations) to be applied on clinical data for validation, set up queries for data retrieval, control workflow of clinical data from creation of collection form and tables until database is locked.
• Identified, resolved and/or initiated the resolution of errors and inconsistencies with the Study Monitor.
• Designed, developed and executed test scripts against Electronic Data Capturing system per user requirement.
• Author Data Management Test Scenarios, Plan and Reports to ensure written procedures for iMedNet (EDC).
• Performed internal QC audits and extensive QA approval of change control using Track Wise.

Confidential

Senior QA Tester

• Strong customer service and interpersonal skills with the ability to work independently.
• Wrote test scripts using different testing types for DB2, MS Visual Basic, Linux, JavaScript to support all regulatory and compliances.
• Wrote oracle, pl/sql schemas/queries to report data for our product services.
• Wrote and Reviewed documentation of software defects then assign developers to investigate and resolve the client issue.
• Wrote, Reviewed and approved test plans, scenarios, scripts and procedures.
• Participated in reviews for functional requirements, product designs, schedules and any potential road blocks.
• Thoroughly tested code functionalities using QTP and scripting languages.
• Supported Dot Net Nuke and Telerik functionalities on MS Server 2003/ 2008 for the VetPro, Epic and PQR Systems.

Confidential

Project Software Verification/Validation Engineer

• Managed and Trained outsourcing partners AVISTA, CHINA and INDIA
• Performed different test types (requirement based, structural analysis, regression, integration, user-acceptance, black-box, white-box, gray-box, ad-hoc, target, manual and visual) using test tools such as V.I.S.T.A./Selenium (IDE)/Eclipse, Load/Performance runner with analyzer decoder, Python, Perl and MySQL.
• Performed Quality Control Internal Audits, Internal & External, and Regulatory readiness for FAA.
• Proficiency in MS Office Project, Software Code and Verification reviews, Subversion, Clear Case and DOORS.
• Followed DO-178 (A, B), CMMI v.3 standards against SDLC and Six Sigma methodology.

Confidential

Project Software Verification/Validation Engineer

• Wrote and executed test procedures during sprints with developers, business analyst project team.
• Reviewed and approved general test procedures, Identified and track abnormal software/system behaviors in tracking systems.
• Reviewed/Validated fixes, documentations (user manuals, installation instructions) for our MES.
• Verified automated user acceptance and integration tests scripts for IBM/SMART client-server POS systems.
• Wrote test procedures and test cases for POS machines during unit test life cycle using VB Scripts.
• Executed third party test and certification scripts and Lean Manufacturing/Six Sigma methodology.
• Implemented Test Automation using VB Scripts and PL/SQL along with Test Status Report/Test Metrics Spreadsheet along with Load/Performance runner (using Smart Bear).

Confidential

Web Developer

• Trained 15+ system administrators to master the ITIL framework for our IT Data Center and Command IT department.
• Installed and tested new versions of Oracle database, applications and patches on Windows 2003 Server.
• Proficient knowledge in MS Visual Basic, Linux, Unix, JavaScript, ASP.NET, MVC, Web Services, HTML and CSS.
• Developed ASP.NET Server Controls such as (events, implementing properties, state management, rendering, templates, data binding, post-back data processing, validation and data binding in .NET Framework v.4
• Created Web Services and Java Script for HTTP protocol such as SOAP for applications exchange information over HTTP, UDDI for communicating with SOAP, WSDL for locating and describing Web Services.
• Designed and created dynamic and interactive web pages for our CMS using PHP which includes PHP basic, forms, advanced, database with MySQL, XML, AJAX and References.