SUMMARY

• 8+ years of industry experience as a Business Analyst wif solid understanding of Business Requirements Gathering, Business Process Flow,Business Process Modelling and Business Analysis.
• Experienced in all phases of Software Development Life Cycle (SDLC), Quality Management Systems (QMS) and project life cycle processes.
• Strong knowledge of FDA QS 21 CFR 820, 211 for Pharmaceutical, Life Science and Health Care Industries and cGMP, GCP, GLP, CAPA, GRP, EMR, EHR &QMS.
• Expertise in implementing the agile, Rational Unified Process and Waterfall Methodologies throughout the Software Development Life Cycle of the project.
• Interacted wif the Stakeholders, End Users to understand and gather stakeholder requirements and create the Business Requirements Document (BRD) and Functional Requirement Document (FRD) and communicating it to the entire team involved.
• Experienced on LIMS configuration, implementation, LIMS Master Data, LIMS Lab Advantage to meet site requirements.
• Domain knowledge in Life Science (Pharmaceutical) and Healthcare (Claims, provider, and member’s area).
• Implemented Unified Modelling Language (UML) methodologies to design Use Case Diagrams, Data Flow Diagrams, Activity Diagrams, Sequence Diagram and ER diagrams
• Lead JAD session and requirements review meetings wif all functional groups and participate in industry events.
• Prepared and executed validation activities for equipment and utilities such as bio safety cabinets, gases, laboratory systems, incubators, stability chambers, freezers, and refrigerators for the start - up facility; actively involved in the implementation of the Labware Laboratory Information Management System (LIMS) Project for Pharmica Biotechnology.
• Prepared and executed validation activities for equipment and utilities such as biosafety cabinets, gases, laboratory systems, incubators, stability chambers, freezers, and refrigerators for the start-up facility; actively involved in the implementation of the Labware Laboratory.
• Experience in validating Laboratory Information Management System (LIMS), Adverse Event Reporting System (AERS), and Chromatography Data System (CDS).
• Experienced in performing Gap Analysis for 21 CFR Part 11 and remediation.
• Validation Laboratory Information Management System (LIMS)
• Thorough knowledge of GRC regulation and policies.
• Defined best practices for Tableau report development and effectively used data blending feature in tableau.
• Extensive experience in reviewing and analysing functional requirement specifications (FRS) and system requirement specifications (SRS) and writing detailed Test Plans, Test Cases, and Test Scripts.
• Excellent experience in working wif FDA regulated environment, GxP (GCP/GLP/GMP) guidelines
• Strong Working Knowledge of SDLC, GRC 21CFR Part 11 and software FDA validation practices.
• Functional experience in Manual and Automated testing tools including planning, design and implementation of tests and test cases, integration, system and regression testing and test efforts documentation management.
• Extensive experience as a validation analyst involved in all phases of SDLC. Conversant wif all aspects of computer systems validation from Requirements to System and User Acceptance Testing and change control.
• Experienced in application 21CFR part 11, GxP and CSV guidelines.
• Good Documentation skills and well versed in all phases of Validated and non-validated testing like Test Planning, Test case estimation, Test Strategy, test case scripting and test case tracking.
• Reviewed and analysed the data design and data flow between various interfaces from Visio documents and Design documents.
• Excellent experience in migration of trail data using EDC systems.
• Strong experience writing Test Plans and Test cases using requirements, use cases and design documents.
• Expertise in manual and automated testing tools (Mercury and Rational Suite of Tools).
• Experienced in software Analysis, Requirements Management, and Quality Assurance and maintain Traceability.
• Excellent Team player and capable of working independently, wif excellent written-communication and interpersonal skills.

PROFESSIONAL EXPERIENCE

Confidential, Natick, MA

Sr. Business Analyst

Responsibilities:

• Created Validation plan for Laboratory Data system and Computer Systems (CDS, SDMS, ELN) interfaced wifLIMS.
• Performed Requirement Gathering & Analysis by actively soliciting, analysing, and negotiating customer requirements and prepared the requirements specification document for the application using MS Word.
• Used ISI Toolbox Pharma Edition efficiently for FDA submissions.
• Performed 21 CFR Part 11 GAP Analysis, Risk Analysis, Developed Requirements, Traceability Matrix (RTM) to track requirements for the software application module. ValidatedLabwareLIMSto meet 21 CFR Part 11 FDA Regulations.
• Worked wif project manager, SMEs and assisted wif the implementation of the Labware LIMS.
• Developed business and system requirements, program functions, best practices (GMP, GLP), FDA validation, and 21 CFR Part 11 conditions in a highly regulated environment, for submission of regulatory documents pertaining to drug development.
• Worked on project life cycle and SDLC methodologies including RUP, RAD, Waterfall and Agile.
• Conducted project kick off meetings wif team members to explain roles / responsibilities, relationships wif other groups, deliverables, timelines, assignments, and status reporting.
• Created views, Stored procedures, and Functions in SQL server for Tableau reporting.
• Build many Tableau reports using Bar Char, side-by-side bars, stacked bars, maps, tree map, pie charts, line charts, interactive reports using Tableau Desktop and Dashboard.
• Wrote PL/SQL statement and stored procedures in Oracle for extracting as well as writing data.
• Actively involved in creating and updating the templates for the different folders and eCRFs in each application based on phase IV trials from CTMS.
• Involved in Functional, Positive, Negative, and Regression testing of Workstation/Equipment automation wifLIMSand Empower.
• Managed and participated in configuration and design of Labvantage LIMS and various lab applications for the Genetic Quality.
• Validation of LabVantage Laboratory Information Management System (LIMS) to be used by Quality Management group to store project related regulatory and non-regulatory documents in a controlled manner.
• Reviewed User Requirements to create Validation Plan and define the validation strategy, Roles and Responsibilities and all deliverables required for Validation of Labvantage LIMS.
• Conducting Internal Audits for each department and related processes to ensure the adherence to Quality ManagementSystem(QMS).
• Highlighting any risks at early stages of Software Development Life Cycle (SDLC) and responsible for Mitigation plan during the testing phase
• Implement CTMS to centralize all trial-related information, and improve clinical data management by equipping staff, including biostatisticians and database administrators.
• Requirements Elicitation, Analysis, Communication, and Validation according to Six Sigma Standards.
• Integrate Data from wide range of sources including in-house clinical data management systems, labs and contract research organizations and perform data cleaning.
• The user reported that the Good Manufacturing Practice (GMP) checkbox is checked which is preventing from dynamic referencing - Remediation successful.
• Extensively worked wif Case Report Forms (CRF) during database design and developed various macros to filter data for phase II and phase III of clinical trials.
• Prepare presentation slides in MS Project, which was extensively used in different JAD sessions and to track progress.
• Prepared dashboards using calculated fields, groups, sets and hierarchies in Tableau. Generated Tableau dashboards wif combination charts for clear understanding.
• Converted existing BO reports to tableau dashboards.
• Authored installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ) deliverables for Labware LIMS
• Involved in validation ofLabwareLIMSby developing, executing, and documenting SOPs, Test Plans and Test Scripts.
• Responsible for validating variousLabwareLIMSfeatures such as like Lab station, Instrument Manager, Folder Manager,BusinessReports and Standards and Reagents Manager.
• Involved in preparing the compliance report featuring the existing status of the cGLP, cGMP sensitive computerized systems.
• Prepared FDA/Regulatory Readiness Reports for IT supported GMP systems that included SDLC documentation assessment, Training completion assessment, Physical and Logical Security, Change Control, Deviations, Disaster and Recovery Planning.
• Extracted data from disparate sources by SAS/ACCESS.
• Developed Traceability Matrix matching URS and UAT for various release efforts forLabwareLIMS. Executed OQ and PQ test scripts and generated Test Summary Reports. Interacted wif the Lead user and wrote PQ scripts and was responsible for User Acceptance Testing (UAT).
• More specifically related to software validation related to CAPA,QMS.
• Involved in writing Complex SQL Queries and creating Custom Reports in Tableau, Testing of Tableau Reports including Data Validation wif different Test scenarios before publishing on Tableau Server
• Participated in performing and communicating Risk Assessment pertaining to Labware LIMS validation to the quality team and higher management.
• Conducted internal audits of theQualityManagement System (QMS) per the documented audit plans and operating procedures.
• Designed and developed Use Cases, Activity Diagrams, Sequence Diagrams, OOAD using UML and Business Process Modelling.
• Created requirements Traceability Matrix to ensure that all requirements have been adequately tested for EDC(InForm), Central Designer and Central Coding.
• Clinical Trial implementation using EDC applications like RAVE and Inform.
• Participated in the bug review meetings, updated requirement document as per business user feedback and changes in the functionality of the application.
• Clarified QA team issues and reviewed test plans and test scripts developed by QA team to make sure that all requirements will be covered in scripts and tested properly.
• Organized meetings to discuss outstanding issues wif QA and developers.
• Wrote test scripts for User Acceptance Testing (UAT).

Confidential, Greenville, NC

Business Analyst

Responsibilities:

• Played an active role in gathering, analysing, and writing Business Requirements.
• Collected and documented Business Processes as well as Business Rules.
• Developed and executed IQ, OQ and PQ protocols, prepared the VSR to summarize all the documentation and instrument validation activities.
• Created templates for method validation protocol, method validation report, standard test method.
• Gatheird URS and FRS for the Chemstation Software and its integration wifLabwareLIMS.
• Assisted in initiating and conducting Gap Analysis and Remediation Plan for lab equipment and software interfaced wifLIMSfor 21 CFR Part 11 compliance and prepared Deviation Reports.
• Prepared specification documents for Lab station module ofLIMSand created test scripts for positive, negative, regression and the validation of Lab station module for interfacing lab instruments wifLIMSLab Ware.
• Provided key input in working wif users in defining project and system requirements.
• Assisted in building a business analysis process model using Rational Rose and Visio.
• Documented the Functional Specifications Document using UML.
• Participated in JAD sessions between the end users and the development team.
• Developed and maintained programs in SAS for UNIX in a user support environment.
• Developed timelines for project delivery and managed projects and resources to successful completion.
• Conducted project related presentations and provided reports to the higher management.
• Conducting user interviews at both in-house and client locations, gathering, and analysing requirements using Agile.
• Build and publish Tableau reports utilizing Data Blending, multi-level hierarchy, Table Calculations, Parameters, Graphs and Actions.
• Actively participated in developing test procedures and test cases to perform manual testing on DSMLIMS.
• Assisted in preparing the Validation Report using the Advance Reporting tool incorporated in the DSMLIMSpackage.
• Performed functional testing and integration testing on the new releases of the application.
• Wrote several complex queries to retrieve data from Oracle and was checked for data integrity.
• Validated the DSMLIMSagainst FDA 21 CFR 11 rules.
• Build parameter list, test methods, specifications, product (variant), sampling plans and the relevant calculations in LabVantage LIMS system.
• Performed Data mapping, logical data modelling, created class diagrams and ER diagrams and used SQL queries to filter data.
• Creating a connection(s), data cataloguing, profiling the data using Informatica EDC and work wif business to standardize the data elements.
• Was responsible for identifying and documenting Business rules, created detailed Use Cases and conducted User Acceptance Tests.
• Was responsible for indexing of the tables in that data warehouse.
• Develop Logical and Physical data models that capture current state/future state data elements and data flows using Erwin.
• Used Quality Center for updating the status of all the Test Cases & Test Scripts that are executed during testing process.
• Evaluated testing results for each potential release build using Quality Center, Quality Center and Bugzilla reports, listing summarized bug information in priority sequence, recommended viability of release for production.
• Involve in preparing Trace Matrix to design test cases.
• Preparing Weekly action report & QA feedback to QA team & Manager.
• Interacted wif the Helpdesk team to investigate and resolve production issues for assuring quality standards of the product.
• Worked throughout the SDLC, which included requirements, specifications, design, analysis, and testing utilizing AGILE methodology.
• Worked on different tools for reporting purposes.

Confidential, Northbrook, IL

Sr. Business Analyst

Responsibilities:

• Involved in the computer system validation (CSV) lifecycle, which matches wif FDA regulations particularly 21 CFR part 11 and validation requirements like reporting features, password regulatory rules, password aging and session time-out for theLIMSsystem.
• Involved in validation ofLabwareLIMSand Open Lab including editing and review of protocols and post execution review for IQ and OQ effort.
• Conducted operational testing ofLabwareLIMSsoftware and involved in writing of Operational Qualification of variousLIMSmodules.
• Collaborating wif the QMO Manager to define and establish the appropriateQualityManagement System(QMS), based on project and client requirements, such as Capability Maturity Model Integration (CMMI), ISO 9001, Six Sigma, and Information Technology Infrastructure Library (ITIL)
• Worked wif internal team, CROs and clinical sites to ensure the tracking and timely conduction of clinical studies.
• Reviewed tools for LIMS decision support to be used by the site. Analysis of LIMS enhancements, troubleshooting issues, second tier application support and routine master data configuration as required wifin the LabVantage LIMS application.
• Configured laboratory information management systems, such as LabVantage SQL LIMS, developing validation master plans and validating LIMS implementations.
• Documented Business Rules, Process flow diagrams, Content Analysis, Performance requirements and user guides.
• Strong knowledge of FDA QS 21 CFR 820, 211 for Pharmaceutical, Life Science and Health Care Industries.
• Researched and documented the laboratory's existing business processes ensuring that a clear and accurate picture of the current state is captured prior to initiation of LIMS upgrading process.
• Developed the system requirements and design of a Documentum application that automated the process of takingCTMSgenerated documents and storing them as PDF.
• Hands on experience in gathering and analysing business processes, translating them into functional requirements and providing technical solutions in life science domain using LIMS.
• Worked wif CTMS to support day-to-day operations in areas such as conducting study feasibility, streamlining the workflow of the trial coordinators and investigators.
• Re-writing the company'sQMSmanual, following new ISO 9001:2015 guidelines and requirements to qualify for the ISO revision.
• Preparing Dashboards using calculations, parameters in Tableau and Developing Tableau reports that provide clear visualizations of various industry specific KPIs.
• Integration of tableau reports wif web application and viewing reports online.
• Developed statistical programs to perform clinical data analysis, review and approve results by using R, SAS and JMP
• Assured that all the validation documentation such as IQ, OQ, PQ followcGMPs.
• Performed Requirement Analysis to understand user needs for data Toxicology/ Pharmacology n-tier system.
• Lead the analysis, design and automation of client/ server applications using Oracle and SQL.
• Worked in compliance wif FDA regulations and cGxP guidelines in all the aspects of Computer Systems Validation.
• Coordinating wif multiple clinical departments IS Teams and vendors to gather requirements and implement application changes in support of department changes and new builds.
• Conducted validation and configuration of LIMS module as per 21 CFR part 11 Compliance.
• Conducted manual testing like functionality, integration, system, positive and negative testing.
• Initiated and performed automated testing of AUT using Quick Test professional.
• Created transition requirement document to allow users to be familiar wif newCTMSSystem.
• Performed validation of laboratory equipment like GC/MS, HPLC, Spectrophotometer and Autoclave in compliance wif cGxP guidelines.
• Involved in documenting the Validation Master Plan in accordance wif FDA regulations, particularly 21 CFR Part 11, GLP and GMP.
• Communicated pertinent LIMS Requirements to site/system owners and gained consensus wif management, IT, QA and scientists of departmental requirements.
• Identified, document business processes for LIMS and captured As-Is and To-be workflow process diagrams to illustrate exchange data between existing CDS and future LIMS.
• Conducted User Acceptance Testing and documented the UAT summary reports.
• Performed front end and back-end testing, GUI, functionality testing and regression testing on AERS using QTP.
• Maintained the requirements traceability matrix (RTM) and mapped the modified test cases as per the new requirements.
• Worked in the application UI to present to the end users wif Tableau dashboards and visualizations on multiple platforms.
• Validated AERS to ensure 21 CFR Part 11, electronic records, electronic signatures and cGXP compliance testing.
• Ensured the tracking of incoming Case Report Forms (CRFs) prior to safety review and upon manual review.
• Participated in the design and review of protocols, documents, regulatory submissions, and reports.
• Identified optimum combination of application solutions to meet the requirements of business functions (LIMS EDMS, CDS, and Project Server).
• Coordinate testing efforts of external systems interacting wif coreLabwareLIMSapplication
• Facilitated and documented the scientific content, its usage, business process standards and technical requirements

Confidential, Fort Worth, TX

Business Systems Analyst

Responsibilities:

• Performed Requirement Gathering & Analysis by actively soliciting, analysing, and negotiating customer requirements and prepared the requirements specification document for the application using MS Word.
• Involved in requirements gathering sessions wif manufacturing division to determine and create the Functional Requirements Specification (FRS).
• Executed Gap Analysis to ensure 21 CFR Part 11 was implemented.
• Performed the requirement analysis, impact analysis and documented the requirements using Rational Requisite Pro.
• Identified opportunities for business process improvement through various meetings wif business users and developers and initiated efforts to make improvements.
• Worked on project life cycle and SDLC methodologies including RUP, RAD, Waterfall and Agile.
• Conducted project kick off meetings wif team members to explain roles / responsibilities, relationships wif other groups, deliverables, timelines, assignments, and status reporting.
• Wrote PL/SQL statement and stored procedures in Oracle for extracting as well as writing data.
• Extensive use of Excel to create Functional Specification Documents & Templates
• Requirements Elicitation, Analysis, Communication, and Validation according to Six Sigma Standards.
• Created GUI specifications wif Page flows, page business actions and screen mock-ups.
• Created RUP activity diagrams and sequence diagrams to analyse the requirements and recommend solutions.
• Develop Logical and Physical data models that capture current state/future state data elements and data flows using Erwin.
• Implementation of Labvantage Laboratory Information Management System (LIMS) including QA and QC Experience
• Prepared scenarios, Use Cases & UML State Diagram for scenarios using Rational Rose.
• Prepare presentation slides in MS Project, which was extensively used in different JAD sessions and to track progress.
• Extracted data from disparate sources by SAS/ACCESS.
• Created Test Scripts (Operational Qualification) to test the functionality of User Specified Customizations and Oracle Reports run through SQL*LIMSv5.0.
• Built dashboards for measures wif forecast, trend line and reference lines. for report development, Tableau reports, Dashboards, Scorecards and handled the performance issues effectively.
• Involved in developing and testing Interface ofLIMSwif various pharmaceutical laboratory equipment’s.
• Assisted the technical team in translating application functionality into application architecture.
• Developed Use Cases, Activity Diagrams, Sequence Diagrams, OOAD using UML and Business Process Modelling.
• Data transfers from text files and Access databases using BCP and DTS; Data mapping and transformations while loading data using VBScript.
• Clarified QA team issues and reviewed test plans and test scripts developed by QA team to make sure that all requirements will be covered in scripts and tested properly.
• Organized meetings to discuss outstanding issues wif QA and developers.
• Wrote test scripts for User Acceptance Testing (UAT).

Confidential, Stamford, CT

Business Analyst

Responsibilities:

• Conducted brainstorming sessions wif executive sponsors, project champion and stakeholders to document problems wif existingCTMSand potential solutions.
• Involved in design and development of Clinical Trial Management System (CTMS) integrated wif EMR and customized to suit protocols following CDISC, GCP and other FDA standards.
• Member of assessment team to study the 21 CFR Part 11 requirements.
• Wrote the Validation Assessment for the management to understand the importance of validation of core business functionality.
• Worked wif project managers and assisted wif the implementation of the LIMS software in compliance wif the FDA 21 CFR Part 11 requirements, using GAMP guidelines.
• Gatheird the User Requirements from the Business Users and the Business Sponsor.
• Developed the Functional Specifications based on the Business User Requirements along wif the Lead Developer.
• Coordinated wif the Lead Developer to set up and build the prototype of the application.
• Reviewed companywide policies and QA procedures.
• Created a Validation Plan based on the Project Scope, Testing Objectives and Testing Plan.
• Wrote documentation for all aspects of the Computer Systems Validation Lifecycle, in accordance wif FDA regulations, particularly Part 11, including: Validation Plan and Protocol, Operation Qualification (OQ) Specification, Performance Qualification (PQ) Specification.
• Created the Test Plan for Protocol Execution and conducted Tester Training for the Test Script Execution.
• Set up the Exception Report Database and coordinated wif the Lead Developer to resolve the bugs that was found.
• Reviewed Vendor Audit and Vendor Compliance report for LIMS software.
• Supervised, executed, and reviewed scripts for the formal validation process wif implementation of cGMP.
• Maintained the Requirements Traceability Matrix (RTM).
• Drafted new SOPs and trained all users on the systems, implications, and impact of 21CFR Part 11 compliant data systems on day-to-day functions.
• Actively participated in project meetings and discussions.
• Peer review deliverables from project team members.
• Scheduled and documented the formal and informal software design reviews.