- Over 8+ years of extensive experience in Business Analysis, Project Management, Software Validation and business process re - engineering with proven ability to articulate business values.
- Facilitate construction of use case design & analysis, use case specifications, scenarios, business processes, work flow diagrams, process flows and technical documents, following RUP & Agile
- Comprehensive knowledge of Waterfall SDLC, Rational Unified Process (RUP) software development process framework, complete UML Artifact, Scope definitions, and AGILE development framework with Scrum, AUP, XP and Six Sigma.
- Working knowledge of implementing software development projects using methodologies such as Waterfall, Rational Unified Process, Agile/Scrum
- Extensive experience in reviewing USR's (User Requirement Specifications) and executing of IQ/OQ/PQ test cases in a GXP environment
- Evaluated collaboration platforms like EMC Documentum, Sharepoint, Confluence Wiki, AtlassianJIRA, Rally and Jive. Proposed the right tool for the project to improve collaboration.
- Expertise in Project Management i.e. Project Scoping, Planning, Estimating, Scheduling, Organizing, Directing, Controlling, Budgeting and Drafting Remedy Procedures.
- Facilitated Change Management across entire process from Project conceptualization to Testing through Project Delivery, Software Development and Implementation Management in diverse Business and Technical Environments.
- Strong Business Analysis Skills including In depth knowledge of Software Development Life Cycle (SDLC), having thorough understanding of various phases like Requirements, Analysis/Design, Development and Testing and Practical knowledge of Rational Unified Process (RUP).
- Experience as Business Intelligence/Systems/Data/Business Analyst with expertise in Pharmaceutical processes, Business Process Engineering, Systems/ Solutions Engineering, Strategic Planning, and Systems Analysis.
- Proficient in developing and debugging MACROS to access, extract, modify, merge, and analyze data and other application for data updates, data cleansing, and reporting.
- Design and review of various documents including the Software Requirement Specifications (SRS), Business requirements document (BRD), Use Case Specifications, Functional Specifications (FSD), Systems Design Specification (SDS), Requirement Traceability Matrix (RTM) and testing documents
- Excellent business writing skills in writing Preliminary Investigation Report, System Requirements document, Systems Design Specification and System Requirement Change Request.
- Wrote simple to complex SQL queries, procedures, views and Functions for validation of Data
- Proficient at creating and transforming business requirements into software requirement specification (SRS) using Rational RequisitePro and designing business models using UML diagrams such as use case model, Class Diagrams, Activity Diagrams, Sequence Diagrams and Collaboration Diagrams in Rational Rose and MS Visio.
- Creative and aggressive self-starter with integrative thinking skills, capable of communicating creative ideas through graphical analysis charts and statistical data display.
Methodologies: SDLC, RUP, UML, CMM,Agile, SIX SIGMA, JAD
Testing Tools: WinRunner, LoadRunner, Test Director and Quality Center
Change Management Tools: Rational Clear Quest, PVCS, Clear Case
Business Modeling Tools: Rational Rose, Microsoft Visio for UML, Business Object and ER diagrams
Project Management: Microsoft Project, Microsoft Office (2010)
Applications: MS Office Suite, Lotus Notes
Reporting/Documentation Tools: Crystal Reports, Rational SoDA / MS Word, Adobe Acrobat, Documentum
Requirement Gathering Tools: Requisite Pro
Sr. Business Analyst
Confidential, Morrisville, NC
- Performed GAP analysis of business requirements (Client) to vendor requirements. Assessed vendor documentation.
- Involved in mentoring specific projects in application of the new SDLC based on the Agile Unified Process, especially from the project management, requirements and architecture perspectives.
- Facilitated JAD sessions with SMEs and business analysts from other feeder systems for a detailed analysis and a better understanding of impact of various projects on each other.
- Clarifying and writing business requirements for a fast-paced agile development model using JIRA stories and Oracle SQL.
- Facilitated the scrum events and managed Agile Lifecycle in JIRA from Planning to Sprint deployment.
- Created functional requirement documents for the impacting projects
- Created UAT plans with several test cases for each project to ensure that the system runs smoothly after the proposed enhancements or changes have been made
- Worked on Documentum for Version Controlling, to maintain up to date changes in the Documents
- Manage changes to requirements through change control -clear case, MQC, Documentum.
- Involved in the design and development of a Middleware component based on Java Webservices which facilitates the communication with Docfinity (Electronic Document Management System).
- Performed numerous Ad-hoc requests, financial reports involving SQL scripts, UNIX, SAS and Teradata.
- Used MS Project to manage schedules, deadlines and resources and collaborate on the project
- Authored Validation plan. Involved in the Design document preparation
- Coordinated Installation Qualification (IQ) activities at the client site
- Involved in the planning and Coordination of testing activities for Operational Qualification (OQ) and Performance Qualification (PQ) Protocols. Involved in documenting test plans
- Coordinated with Business and IT team for the preparation of validation deliverables
- Prepared Requirements Traceability Matrix (RTM) and drafted Validation Summary Report (VSR)
- Worked under tight timelines without extensive support
- Worked on Validation of Legacy Systems in compliance with 21 CFR Part 11.
- Involved in writing the standard operation procedures and safety precautions to be taken for proper handling of analytical instruments like UV spectroscopy Atomic Absorption spectroscopy, Raman spectroscopy, Fourier Transform Infrared Spectroscopy (Fluorometer), Microplate Reader, HPLC, GC and TOC Analyzers.
- Complete 21 CFR Part 11 compliance assessments of laboratory and manufacturing systems
- Validated computerized laboratory equipment like Atomic Emission Spectroscopy (automated in process equipments) based on GAMP 4.
- Managed implementation of Document Management System meeting requirement deadlines.
- Proposed solutions to reporting needs and develop prototypes using SQL and Business Objects that address these needs.
- Responsible for business requirements gathering and technical requirements analysis and documentation for File Net-based document management system
- Managed change control procedure for the customization of legacy laboratory instruments.
- Conducted quality review of existing documentation and validation plans, test scripts, and summary reports both pre and post execution
- Performed dry run and peer run of the authored test scripts to detect deviations and fix the bugs as part of quality review.
- Hands on experience in writing Requirement Traceability Matrix, SOP's, Work Instruction, Risk Assessment.
- Documented user friendly compliance reports for installation qualification, operating qualification and performance qualification validation protocols (IQ, OQ, PQ) in agreement to FDA standards
- Involved in preparation of documents for Computer systems validation documents in accordance to 21CFR, part 11.
- Setup an Interface between the laboratory instruments and the OpenLAB ECM for data acquisition, compliance documentation, storage, retrieval.
- Acquiring all the lab data electronically at its source and a full complement of instrument interfaces.
- Performed user acceptance testing to the check the various functionalities of LIMS.
- Interfaced with the client as part of the Requirements Engineering team to finalize the project scope.
- Assisted the PM in developing Use Cases and project plans and managed changes to the scope of the project.
- Conducted user interviews, gathered Requirements, analyzed the Requirements and managed changes using Rational Suite.
- Managed the project documentation using the Confluence document management system during the entire project cycle.
- Acted as the Documentum D2 SME for transferring from the existing document management system SharePoint by maintaining the project documentation, project folder structures, ensuring the security and access to the appropriate team members in the project.
- Managed Electronic Document Management System (EDMS) for automating R&D and Regulatory document repositories for submissions to the FDA.
- Maintained up-to-date knowledge of EHR software by attending lectures on health information technology
- Implement SharePoint for team collaboration and Document Management.
- Worked on Documentum for Version Controlling, to maintain up to date changes in the Documents.
- 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).
- Conducted interviews with end-users to collect requirement and business process information.
- Implemented data access, storage and validation routines on the database server using Procedural Language/Structured Query Language (PL/SQL).
- Prepared Business Object / Business Process Models that included modeling of all the activities of business from conceptual to procedural level.
- Developed business process models in RUP to document existing and future business processes.
- Created Process Flow diagrams, Use Case Diagrams, Class Diagrams and Interaction Diagrams using Microsoft Visio and Rational Rose.
- Administration of Clinical R&D software including Oracle clinical, Clinapps PMD, Forecasting and sales and marketing software Spotfire and Cognos
- Creating data mapping specifications from the Data warehouse to SAS, Cognos and Microstrategy DataMart.
- Documented output requirements for SAS datasets and reports.
- Involved in mentoring specific projects in application of the new SDLC based on the Agile Unified Process, especially from the project management, requirements and architecture perspectives
- Performed extensive Requirement Analysis including data analysis and gap analysis.
- Designed and developed project document templates based on SDLC methodology.
- Participated in various stages of data and requirement analysis for project needs.
- Identified internal and external system requirements, design and configuration set-up, also created User Documentation and conducted training classes.
- Developed business requirement specification documents as well as high-level project plan.
- Designed and developed Use Cases, Activity Diagrams, Sequence Diagrams, and OOD using UML.
- Assumed ownership of Use Case Diagrams, Use Case narratives and other various artifacts.
- Relieved pressure off the PM by maintaining artifacts and portions of the project binder.
- Documented and delivered Functional Specification Document to the project team.
- Assisted the Project Manager to develop both high-level and detailed application architecture to meet user requests and business needs.
- Participated in the logical and physical design sessions, assisted and developed high and low level design documents.
- Assisted the PM in setting realistic project expectations, in evaluating the impact of changes on the project plans accordingly, and conducted project related presentations.
- Assisted with user testing of systems, developing and maintaining quality procedures, and ensuring that appropriate documentation is in place.
- Conducted User Acceptance Testing (UAT).
- Functioned as the primary liaison between the business line, operations, and the technical areas throughout the project life cycle.
- Performed task decomposition, delegated tasks and monitored project milestones using MS Project.
- Data mapping, logical data modeling, created class diagrams and ER diagrams and used SQL queries to filter data within the Oracle database
- Assisted the PM in performing Risk Assessment, Management and Mitigation.
Confidential, Pittsburgh, PA
- Gathered business requirements by interviewing the Subject matter experts (SMEs), conducting JAD sessions with stakeholders and documented them in a format that could be reviewed and understood by both business and technical teams.
- Performed as a business and technical analyst by translating user requirements into practical/integrated process based solution
- Attended trainings such as EDC-Rave, Oracle Argus Suite and Electronic Document Management Systems (EDM), Change Management and Control, Validation with respect to a specific project
- Good experience using Microsoft SharePoint for document management and as a common repository for project documents and deliverables.
- Utilized Share Point document management system to share documents and to interact with client.
- Worked on Document Management, Service Definition, Workflow Management, Contact Management, Neutrals Management, Activity Management and Communications Management modules.
- Developed and Documented timelines for Project Delivery, and managed Projects and Resources to successful completion
- Utilized MS Office products and Adobe Acrobat for technical writing. Utilized Collabnet as the enterprise document management system for document capture and for version control
- Developed business intelligence reports using Business Objects (BO) tool for the updated results to the stake holder
- Worked along with the Project Manager and other BA's to develop various project plans to track down the time and progress of various projects using MS Project.
- Carried out extensive analysis of the business requirements and subsequently developed high level Use Cases.
- Prepared Use Case diagrams using MS Visio.
- Prepared basic design diagrams including flow charts, data flow diagrams using MS Visio following the UML conventions.
- Converted functional specifications to technical specifications (design of mapping documents)
- Wrote Functional specifications for each of the ETL processes, working in close co-ordination with business users and development leads.
- Reported the overall progress periodically to the Project Management and business stakeholders.
- Maintained Requirements, Traceability Matrices and Attribute matrices using Rational Requisite Pro.
- Worked on Documentum for Version Controlling, to maintain up to date changes in the Documents.
- Worked extensively with the QA team for designing Test Plan and Test Cases for the UAT.
- Conducted User Acceptance Testing (UAT), gathered and documented User Manuals and Business Rules.
- Developed and Tested SAS programs needed to import external data from raw data files.
- Reviewed Stored Procedures for reports and wrote test queries against the source system (SQL Server) to match the results with the actual report against the Data mart (Oracle).
- Analyzed, designed and successfully completed the full product development life cycle of a high visibility, high throughput screening Laboratory Information Management System (LIMS).
- Utilized corporation developed Agile SDLC methodology. Used ScrumWork Pro and Microsoft Office software to perform required job functions.
- XML is used extensively to communicate with web service component and to populate data at the client side
- Created RUP activity diagrams and sequence diagrams to analyse the requirements and recommend solutions.
- Assisted the technical team in translating application functionality into application architecture.
- Clarified QA team issues, reviewed test plans, and test scripts developed by QA team to make sure that all requirements will be covered in scripts and tested properly.
Confidential, Louisville, KY
- Analyzed current business process flow by understanding preset business rules and conditions.
- Designed and developed Use Cases, Activity Diagrams and Sequence Diagrams using UML.
- Involved in Backend Testing to verify data integrity by using SQL.
- Documented, organized and tracked the requirements using Rational Requisite Pro.
- Created Data Flow Diagrams (DFDs), ER diagrams for data modeling and Web-page mock-ups using MS Visio for acceptance from end users.
- Defined project milestones, schedules, and monitored progress using MS-Project and updated plans as required.
- Analyzed and tested Data Interface needs with external systems.
- Analyzed, manipulated and updated Database using SQL.
- Gap Analysis: Analyzed the client's applications programs to determine the impact of the HIPAA rule on EDI Transaction Set and Code List implementation and defined the changes to bring the affected systems into HIPAA compliance.
- Assisted with user testing of systems, maintained quality procedures, and ensured appropriate documentation is in place.
- Maintained Requirement Traceability Matrix (RTM) and Utilized Clear Quest for change requests and defect tracking.
- Claim validation and Pend/Denied Claims Analysis for the Health plans Medicaid programs.
- Worked closely with the technical team to look up for the best possible solution on requirements by keeping business needs and technical constraints in mind.