We provide IT Staff Augmentation Services!

Validation Analyst / Business Analyst Resume

Northbrook, IL

SUMMARY

  • 8+ years of industry experience as a Business Analyst with 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 with 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.
  • 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 with 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 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
  • 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 with 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 with 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.
  • 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, with excellent written-communication and interpersonal skills.

PROFESSIONAL EXPERIENCE

Confidential, Northbrook, IL

Validation Analyst / Business Analyst

Responsibilities:

  • Involved in the computer system validation (CSV) lifecycle, which matches with 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 with 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 with internal team, CROs and clinical sites to ensure the tracking and timely conduction of clinical studies.
  • Documented Business Rules, Process flow diagrams, Content Analysis, Performance requirements and user guides.
  • Developed the system requirements and design of a Documentum application that automated the process of takingCTMSgenerated documents and storing them as PDF.
  • Worked with 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.
  • 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 follow cGMPs.
  • 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 with FDA regulations and cGxP guidelines in all the aspects of Computer Systems Validation.
  • Coordinating with 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 with newCTMSSystem.
  • Performed validation of laboratory equipment like GC/MS, HPLC, Spectrophotometer and Autoclave in compliance with cGxP guidelines.
  • Involved in documenting the Validation Master Plan in accordance with FDA regulations, particularly 21 CFR Part 11, GLP and GMP.
  • Communicated pertinent LIMS Requirements to site/system owners and gained consensus with 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.
  • 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, Project Server).
  • Coordinate testing efforts of external systems interacting with coreLabwareLIMSapplication
  • Facilitated and documented the scientific content, its usage, business process standards and technical requirements.

Confidential, Natick, MA

Sr. Validation Analyst / Business Analyst

Responsibilities:

  • Created Validation plan for Laboratory Data system and Computer Systems (CDS, SDMS, ELN) interfaced withLIMS.
  • 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 with project manager, SMEs and assisted with 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 with team members to explain roles / responsibilities, relationships with other groups, deliverables, timelines, assignments, and status reporting.
  • 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 withLIMSand Empower.
  • Conducting Internal Audits for each department and related processes to ensure the adherence to Quality ManagementSystem(QMS).
  • 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 with 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 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 with 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.
  • 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.
  • 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 with 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.
  • Gathered URS and FRS for the Chemstation Software and its integration withLabwareLIMS.
  • Assisted in initiating and conducting Gap Analysis and Remediation Plan for lab equipment and software interfaced withLIMSfor 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 withLIMSLab Ware.
  • Provided key input in working with 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.
  • 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.
  • Performed Data mapping, logical data modelling, 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 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 with 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, 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 with 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 with 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 with team members to explain roles / responsibilities, relationships with 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 with 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.
  • 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.
  • Involved in developing and testing Interface ofLIMSwith 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 with QA and developers.
  • Wrote test scripts for User Acceptance Testing (UAT).

Confidential, Stamford, CT

Business Analyst

Responsibilities:

  • Conducted brainstorming sessions with executive sponsors, project champion and stakeholders to document problems with existingCTMSand potential solutions.
  • Involved in design and development of Clinical Trial Management System (CTMS) integrated with 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 with project managers and assisted with the implementation of the LIMS software in compliance with the FDA 21 CFR Part 11 requirements, using GAMP guidelines.
  • Gathered the User Requirements from the Business Users and the Business Sponsor.
  • Developed the Functional Specifications based on the Business User Requirements along with the Lead Developer.
  • Coordinated with 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 with 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 with 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 with 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.

Hire Now