SUMMARY

• 8 plus years as Business Analyst wif great passion to business process and System development and implementation wif key focus being a people person, team player and strategic thinker.
• Extensive experience in gathering and managing business requirements, communicating TEMPeffectively wif upper management, developers and QA engineers.
• Excellent facilitation skills in conducting walkthroughs, surveys, questionnaires, interviews, Brainstorming, JAD and JAR sessions.
• Excellent proficiency wif Learning Management Systems including ISOtrain Extensive noledge of cGMP, cGLP, and cGCP.
• Extensive experience in developing Health Care solution for complaint Handling, Investigation, Risk Management, using TrackWise.
• Experienced in implementing cloud based solutions me.e. Veeva Medical CRM for R&D Medical Affairs
• Experienced in implementing veeva including custom mobile solutions such as Vmobile and Irep, CRM Mobile.
• Highly experience wif document management systems including Documentum, SharePoint.
• In - depth noledge of methodologies, specifications and change control of LIMS in pharmaceutical manufacturing.
• Capable to work in a FDA regulated environment wif emphasis on 21 CFR part 11 and experience wif GXP Application Process for Healthcare applications.
• Recognized for expert and precise documentation skills and delivering high quality work products. Drafted numerous Business Requirement Documents and Technical Manuals.
• Requirement gathering, analyzing business processes and proposing improvements in process, identify process gaps, etc. in JD Edwards Order Management and Advanced Pricing modules.
• Worked closely wif JDE Object Management Workbench (OMW) to create versions, design menus and set up UDCs for the different functional areas of JD Edwards.
• Experience working in Siebel Call Center, Siebel Sales and Siebel CRM.
• Extensive experience of Agile SCRUM, Waterfall and RUP methodology.
• Experience in conducting GAP Analysis, SWOT Analysis, and ROI Analysis.
• Expertise in the management of User Request Change, and handling User Conflicts.
• Strong working noledge of Databases, Queries, Data mapping, Data transformations, derivations and writing SQL queries against various databases including Oracle for data analysis.
• Knowledge in developing Test Plans and Test Cases; ensuring adequate testing on software both before and after completion; conducting and documenting UAT.
• Excellent Analytical skills in understanding the business process and translating business requirements into system functionality requirements in technical terms. Developing functional specifications for business process refinement and automation, data modeling, system architecture, conducting feasibility studies, analyzing scope and vision of the project.
• Extensive experience wif process modeling using Unified Modeling Language (UML), preparing graphical depictions of use cases including state diagrams, activity diagrams, sequence diagrams, Data Flow Diagrams (DFD), use case diagrams, including the business workflow using Rational Rose and MS Visio.
• Excellent Team player having work in conjunction wif testers, developers and team members in validation and testing complex projects and in the maintenance of Quality Standards in Projects.
• Self-starter wif excellent business Communication and Presentation skills and capable to work both as part of the team as well as independently to achieve project quality goals.

TECHNICAL SKILLS

Methodologies: Waterfall Model, RUP, Agile Scrum

Databases: Oracle, MS Access, MY SQL, MS SQL

Business Process Modeling Tools: MS VISIO, Rational Rose

Training Management Tools: ISOtrain

Supply Chain Management Tools: MS Project, MS Access

Quality Management: TrackWise, HP Quality Center, IBM Rational Manual Tester

Testing: WinRunner and LoadRunner

GUI/Tools: MSWord, Crystal Reports, IBM Cognos TM1, Siebel OBIEE, Snagit, Photoshop

Documentation Tool: Documentum, SharePoint, MS Office Word/Excel/Power Point

Languages: C, C#, Java, JSP, PL/SQL, HTML, J2EE, .NET, XML

PROFESSIONAL EXPERIENCE

Confidential, Deerfield, Illinois

Business Analyst

Responsibilities:

• Define, design and document business process flows.
• Developed URS and FS Specifications
• Understand and follow appropriate quality GDP, GMP and validation processes and business processes.
• Involved in Validation Master Plan and Qualification Protocol
• Participated in detailed risk assessment.
• Worked wif testing team for IQ OQ Qualification.
• Review test cases to make sure dat all the requirements are being met and covered properly.
• Responsible for UAT, Test Case development and test script execution for Integration, Regression, Performance, Functional and System Testing.
• Communicate concerns, status, and solutions. Disseminate information in a timely manner wifin the team.
• Involved in developing deployment plan and end user communication by region in 3 phases.
• Conducted hyper care calls for end user support after deployment activities and maintain issues log during PQ monitoring phase.
• Regularly generates reports in order to analyze actual department performance versus targeted department performance.
• Identify, analyze, escalate, resolve and document problems and issues dat may impact the business.
• Use technical tools (queries, process maps me.e. standard monitoring) for problem identification and resolution.
• Perform assigned system health maintenance tasks (data corrections).
• Extensively involved in developing and reviewing Job-Aids, Training Material and Communication documents.
• Worked closely wif the business to identify and analyze core business processes and workflows
• Analyzed the existing work flows to identify gaps
• Facilitated workshops as needed for business process analysis
• Initiated meetings/workshops wif other business analysts to ensure the best possible approach to define the complex business requirements
• Facilitated sessions wif users and documented their changes in requests
• Supported the Business users after go live
• Was involved in developing training material and communications
• Developed Test cases, scenarios and performed UAT (User Acceptance Testing)
• Regularly attended weekly status meetings along wif the testing team

Environment: Siebel CRM, TrackWise 8, JD Edwards (JDE) / Hardware Tracking, HP ALM, Cognos BI Oracle, MS-Office, MS-Visio, MS-Access, MS-Project, Share Point

Confidential

Responsibilities:

• Performed thorough business analysis, re-designed business process flow
• Worked wif Baxter and Baxalta business groups to gather requirements for desired solution to replace GQRTS.
• Conducted multiple sessions wif vendors to analyze cost TEMPeffective solution for Baxter’s GQRTS user group.
• Successfully demonstrated the new share point solution wif all the desired features and cost TEMPeffective benefits to the Business and IT groups.
• Performed business analysis, Identified gaps, developed remediation plan.
• Authored Business process flow, User Requirement specifications and Functional requirement Specifications.
• Ensured compliance wif FDA regulations and validation requirements. Implement and maintain validation activities in accordance to 21 CFR part 11 regulations.
• Driven inspection readiness wifin the PMDA team by proactively identifying compliance risks and developing a playbook to insure flawless execution of inspection support.
• Developed Presentations for FDA audit, prepared PMDA Story board, Architectural diagram, Interface diagram and communication plan using MS Visio and PowerPoint.

Environment: Oracle, MS-Office, MS-Visio, MS-Access, MS-Project, Share Point

Confidential

Business Analyst

Responsibilities:

• Gathering requirements, documenting and testing multiple TrackWise solutions including: Deviations, Planned Deviations, CAPA, Complaints, and Change Control.
• Ensured compliance wif FDA data retention and validation requirements. Implement and maintain validation activities in accordance to 21 CFR part 11 regulations.
• Involved in executing unit/system test cases, scripts and plans. Facilitate testing activities using Quality Center Tool and SharePoint.
• Define, design and document business flows and processes.
• Help achieve successful integration of transactional systems (Accessioning, Resulting and Result delivery systems) wif the aid of interviews and JAD sessions.
• Prepared Requirement Traceability Matrices (RTM) and managed every change requests TEMPeffectively throughout the software development life cycle.
• Performed SWOT analysis, GAP analysis for the modules in production, conducted Feasibility study and performed impact analysis for proposed enhancements.
• Used object-oriented analysis and the Waterfall model for business requirements, business processes design (Use Cases using UML).
• Used UML methodologies to design, Document and manage requirements throughout the full lifecycle of the project, me.e. definition, design and testing phases.
• Involved in formulating the test strategy, test plans, test scripts, reviewed QA test plans for appropriate test coverage and conducted system testing (functional, regression and integration testing.)
• Closely interacted wif JD Edwards Purchasing, Logistics, and Order Management TSAs in developing proposed solutions and technical development efforts as a result of which most of the critical system bugs/User error issues are resolved.
• Involved in developing various interfaces from JDE Edwards to Siebel Products Interface, Service Agreement and Customer service request management.
• Developed interface between JD Edwards to Siebel OBIEE for Analytics Reporting.
• Performed system configuration, business process documentation to support system design and integrated Conference Room Pilot.
• Experienced in converting URS document into FDS for Objects Development.
• Part of business team to improve performance, defect testing, and system monitoring.
• Created end-user documentation, provided training, and go-live support.

Environment: Oracle, SQL, SQL Server, MS-Office, MS-Visio, MS-Access, MS-Project, Share Point 2007, Microsoft Office Suite (MS Word, Excel, PowerPoint), XML, JAVA, Waterfall, SOA, Oracle Service Bus, Oracle Fusion Middleware.

Confidential, New Jersey

Business System Analyst

Responsibilities:

• Develop and execute multi-tactic, multi-channel Customer Relationship Management (CRM) programs in support of an upcoming brand launch.Provide support to a Marketing Services Manager (MSM) as part of the Database Marketing Services (DBM) project team.
• Multiple changes of applications are managed through the Shared Application Managed Services framework. The adoption of the framework required Identifying and suggesting the process improvement in existing release/change management process, ensuring all application changes has proper documentation for regulatory compliance.
• Manage day-to-day relationship wif internal and external partners/agencies in support of multi-faceted, complex CRM programs. Document and provide functional guidance to the team for email marketing, direct mail, data entry, telemarketing (inbound and outbound) and digital marketing programs.
• Interact wif brand, advertising/media agencies, vendors, internal marketing services team, and extended teams to execute and analyze online and offline CRM promotional programs. Provide assistance in coordination of scheduling reviews wif the Regulatory Team ensuring alignment wif the tasks wifin the project plan to meet deadlines.
• Coordinate meetings wif key team members across all agencies (internal and external) to plan, review, and execute various CRM projects. Provide leadership and direction for the technology transfer of new products.
• Establish and lead cross functional project teams to launch new pharmaceutical products. Continuously review plan execution against target. Anticipate problems, develop alternatives and ensure key contributors are fully apprised of changes and developments.
• Assure compliance wif the stage contract agreements for all data transfers. Escalate any conflict or potential deviation from the agreed project milestones.
• Managed potential road blocks and proactively resolves problems. Assure compliance wif current procedures and corporate guidelines for preparation of regulatory review.

Environment: RUP, Rational Rose, UML, Use case, Activity/ state diagram, MS Visio, MS Office, Windows 2000/XP, MS Office, SQL, DB2.

Confidential, Houston, TX

Business System Analyst

Responsibilities:

• Experienced in converting URS document into FDS for Objects development, EDI, Z-Table interfaces.
• Part of business team to improve performance, defect testing, and system monitoring.
• Worked wif business users and customer service representatives to clear orders dat are stuck, resolve performance issues, and application/report level errors.
• Supported all issues from JDE Order to Cash, preference setups related to product allocation
• Performed system configuration, business process documentation to support system design and integrated Conference Room Pilot.
• Develop and maintain several new SharePoint sites wif proper permissions for access control and site linking/sharing.
• Proven ability to work independently as well as work alongside the SharePoint Administrator.
• Design concepts, site planning, weekly meetings, and coordinated Q&A sessions.
• Track project schedule updates project activities to monitor benchmarks and capture outstanding issues, and TEMPeffectively communicate goals and strategies wif business partners.
• Acted as a primary liaison between business units/UATs and PMO to develop requirements to meet the determined structure of the project site.
• Create templates, themes, site definitions and maintain document libraries, keeping them updated for key reports and other high level projects, as well as creating landing pages, team site pages, and modifying all site settings.
• Conduct training presentations through Microsoft Live meeting, for newly created SharePoint portals, and presenting instructions through the use of PowerPoint.
• Customize and enhance SharePoint portals utilizing web parts and workflows.
• Build and deploy the infrastructure for a development, test, staging, and production SharePoint environment.
• Extensive use of InfoPath to develop robust forms their by eliminating paper based forms.
• Conducted research and halped determine, whether solutions to business requirements currently exist wifin or outside the business unit, or if 3rd party solutions are feasible.
• Involved in Scrum development process and prepared Sprint burn down chart, product catalog and sprint backlog contain Business Requirements and supporting documents dat contain the essential business elements and definitions as well as the tasks to be completed.
• Prepared RACI matrix for particular enhancements to be done for the business stakeholders and getting approval from the project manager.
• Identified opportunities for business process improvement and initiated efforts to make improvements. Studied project planning and business process. Analyzed existing procedures and reported them to management to improve productivity.
• Conducted walk through sessions wif business users to get sign-offs on the approach document, held meetings and inter team demo of the enhancement wif the developer, system tester, Test lead and release lead after integration testing is done in the test environment.
• Participated in daily UAT status meeting wif all teams involved to resolve outstanding issues.

Environment: Agile SCRUM, Rational Rose, UML, Use case, Activity/ state diagram, MS Visio, Windows 2000/XP, MS Office, SQL, Oracle, HP functional testing software, Microsoft live meeting, Metaman BDC

Confidential, Morgantown, VA

Business Analyst

Responsibilities:

• Documented and Analyzed User Requirement Document, Business Requirement Document (BRD), Technical Requirement Specification and Functional Requirement Specification (FRS)
• Used the guidelines and artifacts of the Rational Unified Process (RUP) to strategize the Implementation of RUP effort in different iterations and phases of the Software Development Life Cycle.
• Worked as an Interface between the Users and the different teams involved in the application development for the better understanding of the Business and IT Processes.
• Followed a structured approach to organize Requirements into logical groupings of essential Business Processes, Business Rules, and Information needs dat insures any Critical Requirements are not missed
• Followed the UML based methods using Microsoft Visio to create: Use Cases Diagrams, Activity Diagrams, State Chart Diagrams, Sequence Diagrams and Collaboration Diagrams.
• Prepared Logical Data Models dat contains set of Entity Relationship Diagrams and Data Flow Diagrams and supporting documents and descriptions of the Relationships between the data elements to analyze and document the Business Data Requirements.
• Worked extensively wif the QA team for designing Test Plan and Test Cases for the User Acceptance Testing.
• Responsible for providing analytical support in the Design, Development and Implementation of Project.

Confidential

Business Analyst

Responsibilities:

• Identifying the user’s requirement for system to be developed and analyze, and design those requirements.
• Carried out regular meetings wif the stakeholders.
• Assisted senior Business analyst wif UML diagrams and in writing BRD.