SUMMARY

• Over 10 years of experience in diverse fields of Business Analysis and Software Quality Assurance.
• Organized requirement gathering sessions, workshops for the business partners across the globe.
• Developed System Process flows based upon Business Requirements.
• Created use cases and end - to-end test scenarios for System Validations.
• Fully conversant with the SDLC and STLC processes.
• Gathered, analyzed and documented business requirements for the new Clinical Trial Management System (CTMS), Supply Chain Management etc.
• Developed business process flows for different projects.
• Worked on reporting tools: Spotfire, Qlik View
• Experience working on GXP projects and conversant with 21 CFR Part 11 regulations.
• Participated in generating the Functional Risk Assessment (FRA), Gap analysis document
• Knowledge of Business Intelligence reports and dash boards
• Developed frontend and backend scripts for application testing on Siebel, Documentum (First Doc) and cloud computing based application. Co-ordinated UAT.
• Worked in Regulated Environment
• Handled multiple projects simultaneously and ability to meet deadlines
• Supported the team during the process of implementation, tracking post production issues until the resolution
• Conversant with Waterfall and Agile methodology

TECHNICAL SKILLS

OS: Windows NT/2007

Software: Siebel, Documentum 5.3, First Doc 4.0, QDoc, HTML, Oracle 8i, SQL Plus, Microsoft Office 2010, Outlook 2010, Internet Explorer 8, Visio, Power Point, ITSM Remedy, Bioclinica iCONDUCT CTMS tool, MS SharePoint, JAVA and .NET application.

Databases: RDBMS, Oracle 8.0

Test Tools: Quality Center 10.0, ALM 11.0, TOAD 8.6.1.0

PROFESSIONAL EXPERIENCE

Confidential, Princeton, NJ

Senior Business Analyst

Responsibilities:

• Change request creation, analysis of the change, risk assessment, completion of all the SOP 003 associated Chang Request documents, managing QDOC (Client Quality System) workflow.
• Analyzing internal user feedback or update releases from vendor doing the analysis based on internal process what is an applicable change and working on next steps to initiate and complete change request.
• Support with authoring of CSV relevant documentations, such as user requirement specification, validation plan, test scripts.
• Interact with business application leads and Process Owner Representatives and participate in R&D IT projects.

Confidential, Branchburg, NJ

Senior Business Analyst

Responsibilities:

• Quality Assurance Plan
• Requirements Specification
• Functional Specification
• Test scripts writing and reviewing
• Requirements Traceability Matrix
• Quality Assurance Summary Report
• Work Instruction
• Involved as a change manager in Remedy
• Daily interaction with the PM, Development team, the business users (SMEs), QA during the process

Confidential, Bridgewater, NJ

Senior Business Analyst

Responsibilities:

• Helped in gathering the documents for the RFP process
• Participated in the vendor demos and vendor selection
• Gathered requirements from the business
• Developed detailed Process Flows for the eStudy
• Developed the data flows between the vendor database and the Confidential data systems for eStudy
• Documented the access of different entities to the systems participating in eStudy
• Supported the project manager maintaining the communication log, follow up with the action items to be performed by the team members, project plan revisions etc.

Confidential, Princeton, NJ

Business Analyst

Responsibilities:

• Authored the User specification document
• Generated Use case diagrams, business process flows
• Developed the Functional specification Document
• Created UAT Test Scripts and the Traceability Matrix
• Coordinated UAT with the global team
• Worked as a reviewer for the scripts executed by the UAT team
• Developed the Test Summary Report and the validation summary report
• Simultaneously worked on other projects (Master Data Management, Mobile Scanning Technology and CMA London Webhosting) with similar responsibilities.

Confidential, Bridgewater, NJ

Senior Business Analyst

Responsibilities:

• User story analysis and prioritization
• Developed process diagrams based on the pain points of the present application using Visio
• Facilitated requirements gathering sessions and translated those requirements into testable functional requirements
• Organized workshops involving the SMEs across the globe from different groups and the vendor
• Participated in meetings with vendors and product managers to ensure that mock up designs satisfy user interface requirements
• Creation of BRD and requirements prioritization for different sprints in Agile
• Documenting functional specification and requirements in ALM
• Involvement with the functional testing
• Acted as a primary link with the Business users (SMEs) and the IT group
• Participated in developing the gap list
• Participated in Functional Risk Assessment (FRA)
• Demoed different modules of the new CTMS tool to the end users

Confidential, Whitehouse Station, NJ

Business Analyst/Data Verification Analyst/QA

Responsibilities:

• Reviewed and analyzed business and functional requirements
• Worked with the vendors to validate the requirements
• Estimated Test effort & schedule
• Developed UAT complex end-to-end scripts and prepared data sets
• Played key role supporting the testers during UAT along with test case execution
• Tracked the defects in ALM
• Provided status report of the overall daily UAT to management
• Developed Traceability Matrix mapping

Confidential

BA/Data verification Analyst

Responsibilities:

• Gathered requirements for data migration and generated the BRD for certain modules in CTMS
• Created the test scenarios and developed the test cases
• Selected protocols and verified data in Spectrum comparing the front end of the legacy system (IMPACT)
• Verified data through backend queries
• Test execution in QC10.0
• Analyzed issues and created discrepancy report log in QC
• Assisted in UAT testing by writing test scripts, preparing screen shots, finding Protocols and helped during the test case execution
• Involved in gathering requirement for extension trial studies
• Experience in creating and analyzing error log after each load, to find out the validity of the dropped data and making decisions on the actions to be taken.
• Experience in Data Cleansing process

Confidential, Raritan, NJ

Computer System Validation Consultant

Responsibilities:

• Monitoring and coordinating IQOQ review process with the reviewers and the engineers using ITSM Remedy,
• Updating the Tracking list for HLM in Share Point
• Collecting data related to the Decommissioned servers to retire from the database
• Updating the PMs about the submitted IQs
• Participating in the meetings and acting as a liaison between the QC group and the Project management group.

Environment: Windows Vista, Share Point, Excel, Word.

Confidential

QA Validation / Migration Analyst

Responsibilities:

• Analyzed user requirements and interacted with Business analyst and the developers regularly to understand the operation
• Developed System Test Design and test scripts for System testing.
• Manually executed the test script for all major functionalities
• Assisted the test case executers overseas to log anomalies and maintained the anomaly log.
• Involved in Unit and Integration testing
• Developed the System Test Report, IQ Report.
• Assisted in UAT Testing,
• Developed the Traceability matrix
• Involved in developing CSM (Computer System Methodology) documents.
• Organized validation documents for archival