We provide IT Staff Augmentation Services!

Sr. Business Analyst Resume

Farmingdale, NY

SUMMARY

  • 8+ years of industry experience as a Business Analyst wif solid understanding ofBusiness Requirements Gathering, Business Process Flow,BusinessProcess Modeling andBusiness Analysis.
  • Expertise in implementing teh agile, Rational Unified Process and Waterfall Methodologies throughout teh Software Development Life Cycle of teh project.
  • Interacted wif teh Stakeholders, End Users to understand and gather stakeholder requirements and create teh Business Requirements Document (BRD) and Functional Requirement Document (FRD) and communicating it to teh entire team involved.
  • Implemented Unified Modeling 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 biosafety cabinets, gases, laboratory systems, incubators, stability chambers, freezers, and refrigerators for teh start - up facility; actively involved in teh implementation of teh Labware Laboratory Information Management System (LIMS) Project for Pharmacia Biotechnology.
  • Experience in validating Laboratory Information Management System (LIMS), Adverse Event Reporting System (AERS), and Chromatography Data System (CDS).
  • Validation Laboratory Information Management System (LIMS).
  • Thorough knowledge of GRC regulation and policies.
  • Extensive experience in reviewing and analyzing 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 analyzed teh data design and data flow between various interfaces from Visio documents and Design documents.
  • 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, Quality Assurance and maintain Traceability.
  • Excellent Team player and capable of working independently, wif excellent written-communication and interpersonal skills.
  • Experienced in being a part of different types of projects COTS Commercial Over teh Shelf Product Customization, Building.
  • Extensive experience in conducting Market Research, Data Analyses, Data Mapping, Risk Identification, Risk Assessment, and Risk management.
  • Worked on teh multiple projects involving teh cross-platform development and testing (Mainframe, Unix).
  • Worked on Pharmacy Benefit Management (PBM).
  • Gatheird and documented requirements for Pharmacy benefit managers (PBMs) for health insurance carriers Coordinate distribution of SOPs to Pharm Sci.
  • Gained extensive knowledge and understanding of MITA, MMIS, Electronic Medical Health Record EMHR and Pharmacy Benefit Management PBM.

PROFESSIONAL EXPERIENCE

Confidential, Farmingdale, NY

Sr. Business Analyst

Responsibilities:

  • Involved in teh 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 OpenLab 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.
  • Worked wif internal team, CROs and clinical sites to ensure teh tracking and timely conduction of clinical studies.
  • Documented Business Rules, Process flow diagrams, Content Analysis, Performance requirements and user guides.
  • Developed teh system requirements and design of a Documentum application dat automated teh process of takingCTMSgenerated documents and storing them as PDF.
  • Worked wif CTMS to support day-to-day operations in areas such as conducting study feasibility, streamlining teh workflow of teh trial coordinators and investigators.
  • Developed statistical programs to perform clinical data analysis, review and approve results by using R, SAS and JMP.
  • Assured dat all teh validation documentation such as IQ, OQ, PQ are in compliance wif cGMPs.
  • Performed Requirement Analysis to understand user needs for data Toxicology/ Pharmacology n-tier system.
  • Lead teh analysis, design and automation of client/ server applications using Oracle and SQL.
  • Worked in compliance wif FDA regulations and cGxP guidelines in all teh 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 Performing front end and back-end testing, GUI, functionality testing and regression testing on AERS using QTP.
  • Involved in documenting teh 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 teh UAT summary reports.
  • Maintained teh requirements traceability matrix (RTM) and mapped teh modified test cases as per teh new requirements.
  • Validated AERS to ensure 21 CFR Part 11, electronic records, electronic signatures and cGXP compliance testing.
  • Ensured teh tracking of incoming Case Report Forms (CRFs) prior to safety review and upon manual review.
  • Participated in teh design and review of protocols, documents, regulatory submissions, and reports.
  • Identified optimum combination of application solutions to meet teh requirements of business functions (LIMS EDMS, CDS, Project Server).
  • Coordinate testing efforts of external systems interacting wif coreLabwareLIMSapplication.
  • Facilitated and documented teh scientific content, its usage, business process standards and technical requirements.
  • Performed impact analysis if claims processing errors are discovered. Worked wif PBM to resolve member pharmacy claims issue.
  • Expertise in documenting precise Business Requirements for various projects in teh Pharmacy Benefit Management (PBM) domain.

Confidential, Natick, MA

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, analyzing, and negotiating customer requirements and prepared teh requirements specification document for teh 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 teh software application module. ValidatedLabWareLIMSto meet 21 CFR Part 11 FDA Regulations.
  • Worked wif project manager, SMEs and assisted wif teh implementation of teh Labware LIMS.
  • Involved in developing 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.
  • Actively involved in creating and updating teh templates for teh 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.
  • 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.
  • Involved in developing SAS programming for extracting data from flat files, Excel spreadsheets and external RDBMS (ORACLE) tables using LIBNAME and SQL PASSTHRU facility.
  • Teh user reported dat teh 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.
  • 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 Labstation, Instrument Manager, Folder Manager,BusinessReports and Standards and Reagents Manager.
  • Involved in preparing teh compliance report featuring teh existing status of teh cGLP, cGMP sensitive computerized systems.
  • 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 teh Lead user and wrote PQ scripts and was responsible for User Acceptance Testing (UAT).
  • Participated in performing and communicating Risk Assessment pertaining to Labwrae LIMS validation to teh quality team and higher management.
  • Designed and developed Use Cases, Activity Diagrams, Sequence Diagrams, OOAD using UML and Business Process Modeling.
  • Participated in teh bug review meetings, updated requirement document as per business user feedback and changes in teh functionality of teh application.
  • Clarified QA team issues and reviewed test plans and test scripts developed by QA team to make sure dat all requirements will be covered in scripts and tested properly.
  • Organized meetings to discuss outstanding issues wif QA and developers.
  • Documented teh requirements for teh member and provider portal and Pharmacy Benefits Management (PBM) Integration on teh member portal, encouraged members to use generic drugs by offering lower copy based on business rules and individual member profiles.
  • Wrote test scripts for User Acceptance Testing (UAT).

Confidential, Greenville, NC

Business Analyst

Responsibilities:

  • Played an active role in gathering, analyzing, and writing Business Requirements.
  • Collected and documented Business Processes as well as Business Rules.
  • Created templates for method validation protocol, method validation report, standard test method.
  • Involved in developing and executing IQ, OQ and PQ protocols, prepared teh VSR to summarize all teh documentation and instrument validation activities.
  • Gatheird URS and FRS for teh 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 Labstation module ofLIMSand created test scripts for positive, negative, regression and teh validation of Labstation 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 teh Functional Specifications Document using UML.
  • Participated in JAD sessions between teh end users and teh development team.
  • Involved in developing and maintaining programs in SAS for UNIX in a user support environment.
  • Conducted project related presentations and provided reports to teh higher management.
  • Conducting user interviews at both in-house and client locations, gathering, and analyzing requirements using Agile and requisite pro.
  • Actively participated in developing test procedures and test cases to perform manual testing on DSMLIMS.
  • Assisted in preparing teh Validation Report using teh Advance Reporting tool incorporated in teh DSMLIMSpackage.
  • Performed functional testing and integration testing on teh new releases of teh application.
  • Wrote several complex queries to retrieve data from Oracle and was checked for data integrity.
  • Validated teh DSMLIMSagainst FDA 21 CFR 11 rules.
  • Performed Data mapping, logical data modeling, created class diagrams and ER diagrams and used SQL queries to filter data.
  • Was responsible for identifying and documenting Business rules, created detailed Use Cases and conducted User Acceptance Tests.
  • Was responsible for indexing of teh tables in dat data warehouse.
  • Develop Logical and Physical data models dat capture current state/future state data elements and data flows using Erwin.
  • Used Quality Center for updating teh status of all teh Test Cases & Test Scripts dat 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 teh Helpdesk team to investigate and resolve production issues for assuring quality standards of teh product.
  • Worked throughout teh SDLC, which included requirements, specifications, design, analysis, and testing utilizing AGILE methodology.
  • Worked on different tools for reporting purposes.

Confidential, Fort Worth, TX

Business Systems Analyst

Responsibilities:

  • Performed Requirement Gathering & Analysis by actively soliciting, analyzing, and negotiating customer requirements and prepared teh requirements specification document for teh application using MS Word.
  • Involved in requirements gathering sessions wif manufacturing division to determine and create teh Functional Requirements Specification (FRS).
  • Executed Gap Analysis to ensure 21 CFR Part 11 was implemented.
  • Performed teh requirement analysis, impact analysis and documented teh 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.
  • 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 mockups.
  • Created RUP activity diagrams and sequence diagrams to analyze teh requirements and recommend solutions.
  • Develop Logical and Physical data models dat capture current state/future state data elements and data flows using Erwin.
  • 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 teh functionality of User Specified Customizations and Oracle Reports run through SQL*LIMS.
  • Involved in developing and testing Interface ofLIMSwif various pharmaceutical laboratory equipment’s.
  • Assisted teh technical team in translating application functionality into application architecture.
  • Developed Use Cases, Activity Diagrams, Sequence Diagrams, OOAD using UML and Business Process Modeling.
  • Clarified QA team issues and reviewed test plans and test scripts developed by QA team to make sure dat 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 teh 21 CFR Part 11 requirements.
  • Wrote teh Validation Assessment for teh management to understand teh importance of validation of core business functionality.
  • Worked wif project managers and assisted wif teh implementation of teh LIMS software in compliance wif teh FDA 21 CFR Part 11 requirements, using GAMP guidelines.
  • Gatheird teh User Requirements from teh Business Users and teh Business Sponsor.
  • Involved in developing teh Functional Specifications based on teh Business User Requirements along wif teh Lead Developer.
  • Coordinated wif teh Lead Developer to set up and build teh prototype of teh application.
  • Reviewed companywide policies and QA procedures.
  • Created a Validation Plan based on teh Project Scope, Testing Objectives and Testing Plan.
  • Wrote documentation for all aspects of teh 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 teh Test Plan for Protocol Execution and conducted Tester Training for teh Test Script Execution.
  • Set up teh Exception Report Database and coordinated wif teh Lead Developer to resolve teh bugs dat was found.
  • Reviewed Vendor Audit and Vendor Compliance report for LIMS software.
  • Supervised, executed, and reviewed scripts for teh formal validation process wif implementation of cGMP.
  • Maintained teh Requirements Traceability Matrix (RTM).
  • Drafted new SOPs and trained all users on teh 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 teh formal and informal software design reviews.

Hire Now