SUMMARY:

• Over all 7+ years of extensive experience working as a Business Analyst in Pharmaceutical, Health Care industries with solid understanding of Business Process Flows, Case Tools, and BI reporting.
• Extensive experience in analyzing and requirements gathering and writing system functional specifications including use cases.
• Have good understanding with entire phases of Software Development Life Cycle SDLC .
• Proficient in organizing requirement workshops, JAD sessions for creating defining Business Requirement Document (BRD), Functional Requirement Document (FRD), Use Case documents.
• Experience on development and Implementation team members in site discovery capturing requirements and systems current state. Develop Requirements and Solution documents, UAT User Acceptance Testing Validation test cases
• Experience in Pharmacy benefit management project and implementation.
• Extensive knowledge of Pharmacy Benefit Management (PBM) working environment and Medicaid and Medicare Part A, B, C, D including processing Retail pharmacy claims, FACETS, Direct claims and Mail - Order Pharmacy claims. Also, extensive knowledge of PBM's Drug Management Lists (DML)
• Comprehensive knowledge of SDLC Methodologies like Waterfall and RUP.
• Expertise in broad range of technologies, including business process tools such as Microsoft Project, Primavera, MS Access, MS Visio, technical assessment tools, Data Warehousing concepts and web design and development.
• Excellent experience in working with FDA regulated environment, GxP (GCP/GLP/GMP) guidelines.
• Having extensive Industry experience as a Business Analyst with solid understanding of Business Requirements Gathering, Data warehousing, Data Modeling, Evaluating Data Sources, Translating Requirements into Specifications, Application Design.
• Strong knowledge and understanding of Good manufacturing practices (GMP) and FDA Standards.
• Competent in Creating Unified Modeling Language (UML) diagrams such as Use Case Diagrams, Activity Diagrams, Class Diagrams and Sequence Diagrams.
• Strong experience in conducting User Acceptance Testing (UAT) and documentation of Test Cases. Expertise in designing and developing Test Plans and Test Scripts.
• Experience working within a 21 CFR Part 11 compliant environment.
• Demonstrated ability to work well with a wide variety of people at various levels, foster cooperation and collaboration among individuals in the work unit, help team resolve conflicts constructively and ability and willingness to communicate when help is needed.
• A Self starter with a positive attitude, willingness to learn new concepts and acceptance of challenges.

TECHNICAL SKILLS:

• Windows 7/8/Vista, 2000, 2008 server
• MS Office 2010/2007
• RUP
• UML
• SDLC
• Waterfall
• Oracle
• Java
• .Net
• Quality Center
• LoadRunner
• WinRunner
• UAT
• QTP
• Labware LIMS
• Data warehouse
• ETL
• Informatica
• MDM
• Business Intelligence BI
• QA
• WAP
• MS Access
• SQL Server
• MySQL
• PL/SQL
• Oracle DBA
• DB2.basic UNIX
• HTML basic DHTML basic XML
• MS Office Suite-Excel Macros
• Project
• Visio
• Data Stage
• Rational Rose
• Enterprise Architect
• DOORS
• CaliberRM
• Crystal Reports
• Cognos
• C
• C++
• SharePoint
• Docushare
• BASIC
• Intermediate level-Visual Basic.

PROFESSIONAL EXPERIENCE:

Confidential, Cecil Township, PA

Lead Business Analyst

Responsibilities:

• Analyzed the business and functional requirements of the application and developed detailed test plans, test cases in Test Director.
• Utilized corporation developed Agile SDLC methodology.
• Worked on Validation Lead, Abin has authored and reviewed Validation deliverable's including Validation Change Request (Initiative), System Risk Assessments, Validation/Project/Migration/Sampling Plans, Supporting System Documentations, Validation Test Protocols, Requirement Traceability Matrix, User Acceptance tests, Validation summary reports and System Certification.
• Created baseline requirements in compliance with Computer System Validation.
• Designed and authorized Validation Plan, Test Estimation, Requirement Traceability metrics, Validation Test Cases, Validation summary reports, Incident Report, Risk Assessment document, eRIM, DPP and System Certifications.
• Serve as a liaison between the business community and the IT organization in order to provide technical solutions to meet business needs for the Guest Refill project and other pharmacy benefit management projects.
• Tested and implemented as per 21 CFRPart11 and GMP guidelines.
• Trained laboratory analyst to perform sterility testing. Comply with all GMP guidelines.
• Provided an independent review of the project deliverables to ensure that they meet the GxP, CAPA, 21 CFR regulatory expectations and standards.
• Performed Gap Analysis, Impact Assessments, Risk Assessment, 21 CFR Part 11 Assessments and Internal Audit Assessment to ensure SOP compliance.
• Working knowledge of implementing software development projects using methodologies such as Waterfall, Rational Unified Process, and Agile/Scrum.
• Data extraction and reporting from LIS (Laboratory Information System) to analyze them for business and technical specifications.
• Used SDLC (System Development Life Cycle) methodologies like the RUP and the waterfall.
• Worked on pharmacy benefit management systems to make use of our existing web applications that provide pharmacy/Rx related member functionality.
• Ensured that the Laboratory Information System met with all regulatory requirements, and that all departments maintained proper documentation relating to result input, validation of results and other pertinent information
• Elicit requirements utilizing interviews, document analysis, BRD/FRD requirements, and surveys.
• Formulated documents as per business requirements for existing and future business systems in the Pharmaceutical Environment.
• Identified, researched, realized, investigated, analyzed, defined and documented business processes and Use Case Scenarios under good GxP Quality Standards.
• Responsible for the on-site component of the implementation and update of a new/upgraded Laboratory Information System.
• Worked with Documentum Enterprise content management (EDMS) using pharmaceutical GxP standards to capture, store, preserve and deliver content and documents related to organizational processes with Every Document Now Available (EDNA).
• Identified opportunities for business process improvement through various meetings with business users and developers and initiated efforts to make improvements.
• Entered lab orders into Epic (Hospital information system) and Sunquest (Laboratory information system).
• Work with the full SDLC, elicit, analyze and define requirements.
• Review requirements and understand technical recommendations and constraints, and develop comprehensive and accurate functional specifications; Data Mapping, and process flows.
• Prepared Business Requirement Document, manage, analyze, and convert business requirements into KPI's for MDM
• Worked on Documentum for Version Controlling, to maintain up to date changes in the Documents.
• Master Data Management: Provided data management expertise for MDM project; Developed initial testing plan, testing requirements and testing scripts.
• Create Business Requirement (BRD), Functional Requirement (FRD), Use Case Documents, rules, and workflows.
• Assigned tasks among development team monitored and tracked progress of project following agile methodology.
• Analyze user needs to determine functional requirements, leveraging laboratory and quality system experience in an Agile environment.
• Designed and developed project document templates based on SDLC methodology.

Environment: RUP, UML, UAT, Windows 7, Java, .Net, MS Office, Team foundation server TFS, Aglie/Scrum, Web services, BRD, FRD, Rational Rose and Requisite Pro, MS Visio,MS Project, XML, HTML, J2EE (JSP1.2), XSL, XSLT, HTML, Oracle .

Confidential, NYC, NY

Sr. Business Analyst

Responsibilities:

• Gathered and analyzed the requirements and converted them into Business Requirement Specifications (BRS) and Functional Requirement Specifications (FRS) for the designers and developers and QA Team to understand them as per their perspective.
• Coordinated update across all sites working with users, IT and Quality, ensuring GMP (Good Manufacturing practices) processes were followed, and all testing and documentation met Confidential ’s internal GMP standards.
• Prepared Test Summary Reports/Validation Summary reports on the actual results generated during Test Execution.
• Performed Documentum Requirement Analysis and developed Use Cases and Activity Diagrams.
• Identified opportunities for business process improvement through various meetings with business users and developers and initiated efforts to make improvements.
• Wrote Business Requirement (BRD), Functional Requirement (FRD), Use Case Documents.
• Met requirements of both end user ways of working and FDA electronic data capture.
• Working with clients to better understand their needs and present solutions using structured SDLC approach.
• Generate weekly and monthly reports to facilitate the tracking of departmental metrics and FDA compliance rating.
• Generate periodic reports for internal/external distribution to Regulatory Affairs and the FDA.
• Conducted, involved and made Minutes out of JAD sessions which included BRD, FRD.
• Created BRD documents and Maintained Documents in Team Share point.
• Creating FRD, Functional Requirement Documents.
• Responsible for storing and maintaining the documents to comply with 21 CFR Part 11requirements.
• Performed Gap Analysis, Impact Assessments, Risk Assessment, 21 CFR Part 11 Assessments and Internal Audit Assessment to ensure SOP compliance.
• Analyze & Create BRD, Business Requirement Document whi le providing them with multiple options.
• Had to work closely and communicate effectively with business customers, other IT groups,management, and external vendors to implement business and/or system solutions addressing specific needs of a business area or process.
• Demonstrated experience implementing MDM foundational programs such as master data security, master data quality, master data workflow, etc.
• Planned and managed deliverables of multiple projects simultaneously.
• Analyzed and documented business requirements and Creates functional requirements specifications.
• Played an active and lead role in gathering, analyzing, and writing business requirements.
• Gather requirements by conducting meetings and brainstorming sessions with end users and SME and document them.
• Interviewed customers to identify systems impacted and improvement needs and document results using various documentation and tracking systems, led JAD sessions.
• Implemented training for business workflow users and MDM staff.
• Created story cards and story mockups for requirements gathering.
• Prepared user acceptance criterion and testing strategy that will be utilized by QA team to validate the addressed functionality of all critical requirements.
• Developed and maintained Test Matrix and Traceability Matrix. Utilized Quality Center to plan and execute tests, track defects and create change alerts. Conducted User Acceptance Testing (UAT).

Environment: Windows Xp pro, Microsoft Office, SharePoint 2007, Rational Requisite Pro, MS Office, SQL Server, J2EE, Agile,UNIX, Powerbuilder, Sybase, MS Project, MS Access, Documentum,UML.

Confidential, Cambridge, MA

Business Systems Analyst

Responsibilities:

• Responsible for defining the scope and implementing business rules of the project, gathering business requirements and documentation.
• Responsible for writing Functional Requirement Specifications (FRS) and User Requirement Specification (URS).
• Analyzed Business Requirements and segregated them into high level and low level Use Cases, Activity Diagrams / State Chart Diagrams using Rational Rose according to UML methodology thus defining the Data Process Models.
• Understand the As Is system and develop the To Be system concept and also prepare the System Process Maps.
• Write BRDs and User acceptance test case.
• Responsible for all Builds, Build Validation Testing, Regression, Verification and Validation Test.
• Worked on discrepancies between actual and expected data validation test results.
• Used T-SQL for Querying the SQL Server database for data validation and data conditioning.
• Review FRD and Dev and QA test cases.
• Identified, researched, realized, investigated, analyzed, defined and documented business processes and Use Case Scenarios under good GxP Quality Standards.
• Managed internal R&D and client sponsored web based projects.
• Assured Process Validation, Cleaning Validation, and Software Validation in compliance with cGXPs (cGMP, GLP).
• Working knowledge of implementing software development projects using methodologies such as Waterfall, Rational Unified Process, Agile/Scrum.
• Functional Requirements of the COTS products and evaluated the integration of COTS with the existing system.
• Created the configuration document for custom setup for various user groups such as marketing, R&D & sales, research analyst & investigators.
• Defined user access rights & permission matrix for the clinical trial documents.
• Used SDLC (System Development Life Cycle) methodologies like the RUP and the waterfall.
• Performed extensive Requirement Analysis including data analysis and gap analysis.
• Successfully conducted JAD sessions, which helped synchronize the different stakeholders on their objectives and helped the developers to have a clear-cut picture of the project.
• Conducted meetings and invited System Analyst, Business Representative and Prototyper to allow different stakeholders to communicate their perspectives with each other, and thereafter documented Business Requirements using iRise Manager for final approval or for future discussion.
• Created Process Flow diagrams, Use Case Diagrams, Class Diagrams and Interaction Diagrams using Microsoft Visio and Rational Rose.
• Wrote Test Cases and performed User Acceptance Testing, documented the in detail defects using the Defect Tracking report.

Environment: Microsoft Office Suite, Microsoft Visio, Documentum, Windows XP, Oracle, SQL, SQL Server, Sybase, RUP,VBScript, SharePoint, Unix, Caliber RM, ASP.NET, Business Objects, TestDirector, LoadRunner.

Confidential, Minnetonka,MN

Business Analyst

Responsibilities:

• Involved in the full HIPAA compliance lifecycle from GAP analysis, mapping, implementation, and testing for processing of Medicaid Claims.
• Followed solely RUP methodologies during the course of the project.
• Upgraded the existing Test Scripts and created new scripts for client application to be able to work for new versions and patches, which improved product quality.
• Created Data Stage jobs to extract, transform and load data into data warehouses from various sources like relational databases, application systems, temp tables, flat files etc.
• Responsible for technical Design for the Health Information Technology HIT, Electronic Health Records (EHR) Incentive Payment Program.
• Managed open enrollments/yearly group renewals with eEnroll/eExchange/HRIT groups for all Active/Cobra/Medicare/Medicare splits members.
• Involved in mentoring specific projects in application of the new SDLC based on the Agile Unified Process, especially from the project management, requirements
• Helped with data modeling and defining the conceptual and logical model of the data warehouse.
• Used Agile Software Development methodology for developing the application.
• Worked with HIPAA rules and regulations to draft business rules and claim processes.
• Extensive Data Warehousing experience using Informatica as ETL tool on various databases like Oracle, SQL Server, Teradata, MS Access.
• Worked on Procedure codes, Provider types, Service types, Specialty codes and Diagnosis codes.
• Performed Data mapping, logical data modeling, created class diagrams and ER diagrams and used SQL queries to filter data.
• Conducted JAD sessions with management, SME, vendors, users and other stakeholders for open and pending issues.
• Assisted in the development, design and implementation of new relational or multi-dimensional databases, including the analysis of user needs.
• Worked extensively with MS Excel and MS access.
• Performed data analysis by using SQL queries.

Environment: Rational Enterprise Suite (Rose, RequisitePro, ClearCase, ClearQuest), MS Office, Oracle, DB2, Sybase, SQL Server Reports, WinRunner, LoadRunner, Quick TestPro.