SUMMARY:

• Data and Business Intelligence Analyst with more than 7 years of experience supporting data driven systems for healthcare, industrial and technology organizations.
• Expert in creating databases and various SQL server objects like schemas, tables, indexes, indexed view as per the specifications and requirements to meet the business functionality.
• Designed SSIS Packages to extract data from various data sources such as SQL Server, Access database, Excel spreadsheet, xml files and flat files into SQL Server database for further Data Analysis and Reporting.
• Experience in electronic medical coding (CPT/ICD/EDI) and Experience creating dashboard for healthcare billing and managed care monitoring as well as to monitor areas for improvements (AFI), and performance indicators (KPI). Experience generating data for FDA.
• Compliance assisted with implementation of new laboratory information management system (LIMS) database, Lab Works by Perk and Elmer, for capturing data for lakes, streams and environmental hazards. Specializes in collecting, analyzing and maintaining business and healthcare data to generate information and reports.
• Proven history of utilizing strong analytical skills, attention to detail, and hard work ethics to turn complex requirements into working systems. In - depth knowledge of various Software Development Lifecycle (SDLC) methodologies such as Waterfall, Agile and Scrum.
• Worked with vendor on installation of scripts and troubleshooting bugs and Assisted users with configuration needs and work with LAN and WAN team to implement processes.
• Recommended process improvements based on troubleshooting issues.
• Delivered mass amounts of data to regulatory programs, analysis of data, and checking complex calculations for back end configurations.
• Experience in gathering requirements, Business analysis, writing validation test scripts, user acceptance testing and user training and unit testing.
• Extensive experience in Software Design, Programming and Testing and project management.
• Experience with developing GxP Change Control documentation and validation test scripts based on internal validation methodology.
• Experience in Computer system validation using GAMP and GMP guidelines.
• Customer service oriented, strong analytical, problem - solving skills and experience generating various reports.
• Dedicated team player with excellent communication, organizational and interpersonal skills.
• Familiar with current industry standards, such as HIPAA, GXP, FDA 21 CFR Part 11, CAP and CLIA Guidelines Ability to learn new technologies within a short time.

PROFESSIONAL EXPERIENCE:

Confidential - Menlo Park, CA

Sr. LIMS Business Analyst

Responsibilities: -

• Lead role to Configure and Customize Labware Electronic Laboratory Notebook to all labs. And Working on Labware Automation projects.
• Expert technical knowledge and experience with SQL (writing SQL queries), Crystal Reports, Excel and Access.
• An excellent team member with an ability to perform individually and interpersonal relationship, good communication skills, hardworking and high level of motivation.
• Proficient in SQL, T-SQL, PL/SQL Programming with exposure to RDBMS using Oracle, SQL Server.
• Provide primary support for 2 US LIMS software deployments and secondary support for 3 Canadian deployments HTML, JavaScript, Visual Basic, SQL • Train and support internal and external clients and Maintain local hardware.
• Execute business analysis processes to facilitate the user/function/design relationships within the LIMS system including documentation and test scripting.
• Build and support Lab Ware LIMS specific processes like batch/lot creation, quality disposition, and sample chain of custody.
• Extensively involved in Data Modeling. Generating various reports using complex sql's.
• Experience in genomics LIMS System using Labware for Genomics Department.
• Implemented crosstab reports and running the macros in excel from Labware LIMS to generate crosstab style reports.
• Good experience in report customization via the use of Grouping, Sorting, Field Highlighting, Conditional Formatting, Running Totals, Summaries, Static & Dynamic Parameters, Static & Dynamic Graphic Objects, Custom Formulas and Custom Functions (SQL Queries).
• Support for Core LIMS, EM LIMS and AHS LIMS and resolve issues in a timely manner.
• Manage Static Data and adding new entries in the system and Working closely with LIMS automation manager to automate the Laboratory Process in Biologics, Analytical Chemistry and Animal Health Sciences.
• Experience in integrating clinical instruments with Labware LIMS and Familiar with stability and environmental monitoring and Pharma template module.
• Support and User training and management of users and roles.

Confidential, Concord, CA

Business Analyst

Responsibilities: -

• Project management for the Labware LIMS implementation in the HIV Diagnostics and Reference Laboratory.
• Demonstrate new object functionality to Business Owners in the systems Development environment.
• Communicate and facilitate with groups of Business Users throughout User Acceptance Testing to ensure all critical business cases and needed functionality is working as per original requirements.
• Strong written and verbal communication skills, including the ownership of SDLC governance documentation such as business requirements, functional specifications, systems testing, and technical design.
• Interacted with HJF IT infrastructure team to build the LIMS Dev, Test, and Production systems as per the vendor recommendations.
• Interacted with various business stakeholders (Director, Sr. Scientists, Lab Managers, Supervisors, and Technicians to gather requirements and implemented them in a timely manner.
• Identify opportunities for improvement and develop business cases for various system changes and enhancements.
• Identified and re-engineer inefficient processes to achieve a higher level of quality and productivity.
• Create and foster successful business relationships with internal and external (NAVY) business and technology counterparts.
• Experience in LIMS Basic Development, labware LIMS modules installation and Building an Installation Kit and Static and dynamic data migration from any LIMS software to Labware LIMS.
• System configuration - creates analyses, setup toolbars, migrate modules from development to production, create and manage security roles. Instrument integration / interfaces. Interact with project teams, IT and management to define/collect user requirements. Conduct change management activities (for business) in support of system upgrades.

Confidential, East Hanover NJ

Business Analyst

Responsibilities:

• Worked on configuration and customization of Viromed Data Migration project (~9 million records) and integrated with LIMS. Wrote controls files to load data using SQL Loader into LIMS Oracle Database. Wrote various Oracle procedures, functions and Triggers.
• Worked with Patient Manager, Order Manager and Reference Range Manager modules and designed Assay reflux based on the algorithm and business rules.
• Evaluated software releases, gather requirements, test and implement upgrades, prepare documentation and train end users.
• Project management of new module configuration and implementation for MSOW including electronic medical staff office credentialing and provider applications.
• Support SAP (PP/MM) systems as End user in Material Management and production planning and Support operations as per GMP, GLP and SOP guidelines.
• Maintain CAPA documents, SOPs Manufacturing tracking software for production assemblies. Design process flow and specifications.
• Crystal Reports Deliver solutions that meet or exceed the needs of management, internal and external clients while improving processes and maintaining current systems with 99.9% uptime.
• Managed the commercial launch of QLab, the SGS client-facing results and reporting website Quality System & Standard.
• Manage disaster recovery and business continuity documentation for operations involving LIMS implementations.
• Performed quality assurance by coordinating and developing testing for upgrades and fixes including requirements gathering, unit testing, managing testers and training end users.
• Investigate, report, and resolve MSOW software issues with vendor.
• Created and maintained Crystal Reports that are integrated into MSOW.

Confidential - Greensboro NC

Business Analyst

Responsibilities: -

• Analysis of the Business requirements and Performance requirements of the medical instruments and associated software, validating their functional performance according to FDA, ISO 9000, IEEE and Corporate Standards.
• Responsible for providing technical expertise regarding commissioning and qualification of the Texas, software, systems and equipment.
• Participation on software project teams to review and analyze software documentation/project deliverables associated with the Software Development Lifecycle.
• Developed the validation test plans for quality assurance of the medical instruments in accordance with regulatory standards.
• Generation of test protocols for software testing and validation.
• Responsible for executing and developing compatibility validation tests.
• Perform statistical analysis, process capability analysis, FMEA, FTA (Fault Tree Analysis) hazard analysis.
• Developed test plans, test protocols for software enhancements and changes.
• Provide technical support for commissioning activities (e.g. receipt verification, factory acceptance testing, functional testing, etc.).
• Provide support for qualification activities (e.g. Design Qualification, Installation Qualification and Operational Qualification) as the system is developed and installed.
• Performed integration, interface and system testing. Performed load testing on the OAS server, which is connected to the OSP Instrument.
• Interacted with developers to fix the software defects. Provided Support and Technical training to Users Group.