LabWare LIMS Consultant Resume Profile, Irvine, CA

Reference Id: 10715     Posted on Wednesday 11th March 2015      Others



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LabWare LIMS Consultant Resume Profile, Irvine, CA

SUMMARY


  • Four years of Labware LIMS consulting experience in developing and validating custom solutions for different clients in Pharmaceutical and Biomedical Device industry
  • Excellent knowledge and experience in configuring LabWare LIMS v5 including its different modules namely Lot Manager Stability Study Manager Environmental Monitoring Batch Manager Inventory Manager Investigation Manager
  • Sound knowledge of LabWare Architecture Database LIMS Basic Configuration and SQL queries
  • Designed and configured interfaces with laboratory instruments using LabStation and with systems eg Empower SAP
  • Developed Crystal Reports and NWA Charts for different user requirements for different modules
  • Other programming experiences include developing database driven web applications using Python Google App Engine Javascript Jquery JSON Google Maps API Foursquare API Yelp API
  • Hands on experience in writing technical documentation for all aspects of the Computer Systems Validation CSV lifecycle including User/Functional Requirement Specifications/ Systems Requirements Specification Installation Qualification Operational Qualification OQ Performance Qualification PQ test plan and test scripts Training Manuals Standard Operating Procedures SOPs Work Instructions and Validation Summary Reports
  • Experience in carrying out integration system performance and UAT testing
  • Experience in developing Test Plans Test Cases Test Scripts and Test Procedures
  • Excellent knowledge of cGXP and 21CFR Part11 standards and strong knowledge of laboratory and process operations of Pharmaceutical and Biomedical Device industries
  • Twelve years of diverse work experiencein Application Development Computer Systems Validation Quality AssuranceResearch Process OperationsandTechnical Services makesit possible to handle new problems and situations effectively
  • Motivated resultsdriven Consultant Proven performer and quick learner
COMPUTER SKILLS LIMS Crystal Reports SAP Empower RDBMS DCS SAS Windows MS Office Visual Studio Visual Web Developer SQL Server Mgt Studio Eclipse

PROGRAMMING SKILLS LIMS Basic Python NET C VB JavaScript JQuery HTML CSS

PROFESSIONAL EXPERIENCE



Confidential
LabWare LIMS Consultant

Confidential is implementing LabWare LIMS V5 for global operations and R D organization throughout Confidential manufacturing and research facilities worldwide The LIMS System will manage the processes of lot management sample submission sample inventory maintenance stability monitoring environmental monitoring inprocess testing batch/product release testing and reporting for laboratory samples from clinical and commercial manufacturing operations
The LIMS implementation involved implementation of Lot Manager Batch Manager Environmental Monitoring Inventory Manager Stability Study Manager Investigation Manager Standard Reagent Manager Empower Interface and SAP Interface Crystal Reports and NWA Charts were integrated with LabWare LIMS and all reporting was done through Crystal Reports I contributed in development and configuration of the LIMS system to provide custom solutions

Responsibilities



  • Involved in configuring coding testing debugging documenting and implementing LIMS
  • Analyzed requirements and created functional specifications
  • Wrote LIMS BASIC custom programs for creating user interface as well as data mapping to oracle database
  • Created workflow for Lot Manager Environmental Monitoring Standard Reagent Manager
  • Configured and coded new Lot Templates Sample Login Templates Product Specifications Inventory Filters Event triggers Subroutines User Dialogs etc
  • Interfaced with laboratory instruments using LabStation
  • Performed Risk Analysis for new modules as well as system changes to existing modules to expose all the risks associated with the requirements and to define whether testing is required to mitigate the risk
  • Trained System Administrators and Site Personnel on LIMS
  • Assisted Test Director and Script writers in carrying out/ developing Risk Analysis IQ OQ and Traceability Matrix
  • Developed User Acceptance Test UAT test cases for the added functionalities
  • Developed more than 30 Crystal reports and NWA Charts
  • Helped System Administrator to create multiple application environments for user testing and created a process to easily migrate new code objects and static data across environments


Web Application Developer Jun 2009 Present

Developed a social networking web application to provide platform for people to connect for different interest areas like classifieds articles restaurants etc Using Google App Engine Python JavaScript HTML DHTML CSS different APIs to create rich and interactive web application Also assisted in creating Contact Management Tool using ASPNET VB Visual Web Developer and SQL Server Management Studio


Confidential
Computer Systems Validation Engineer

Confidential is the worlds leading developer and manufacturer of breakthrough products for interventional medicine minimally invasive computerbased imaging and electrophysiology Cordis is implementing LabWare LIMS V5 at their headquarters at Warren NJ LabWare LIMS is a fullfeatured configurable enterprise Laboratory Information Management System LIMS It is designed to be completely customer configurable providing an unparalleled degree of client involvement in adapting the software to their specific needs
The LIMS implementation included migration of existing core LIMS functionalities from their Puerto Rico site and implementation of new advanced modules like Stability Study Manager Lot Manager and Batch Manager I contributed in development of all documentation required for validating the LIMS implementation This involved updating the existing validation documents for the new implementation

Responsibilities



  • Developed Validation Strategy Document Validation Master Plan to define validation strategy for the LIMS implementation
  • Updated User Requirements Specification URS and System Requirements Specification SRS to include new requirements as well as update the existing requirements
  • Performed Risk Analysis for new modules as well as system changes to existing modules to expose all the risks associated with the requirements and to define whether testing is required to mitigate the risk
  • Assisted in development of Technical Design Document and IQ/OQ Protocol
  • Developed Validation Protocol in parallel to the LIMS Configuration to adhere to strict project timeline
  • Prepared Requirement Traceability Matrix for linking URS SRS and Test scripts
  • Validated the LIMS interface with Waters Empower Chromatography Data System CDS Developed protocols for creating a new sample set and sample data transfer to Empower and results retrieval from Empower
  • Validated the entire configuration incorporated in the existing LIMS application The changes involved incorporation and configuration of laboratory work flow Lot Manager Batch Manager and Stability Study Manager
  • Drafted test scripts for validating the complex requirements of the Stability Study Manager like editing timepoints conditions positions tests in a protocol putting these on hold/unhold editing sample quantities verifying and updating the sample inventories and integration of the Stability module with Lot Manager and Inventory Manager
  • Validated Crystal Reports and LIMS calculations for different analyses tests like USP 4 USP 7 Assay Drug Content Uniformity etc
  • Validated sample label preparation barcode scanning and label printing applications
  • Efficiently interacted with LIMS Developers System Administrators laboratory personnel users and other dependent departments


Confidential
Technical Writer

Confidential is the worlds largest medical device company dedicated to lessinvasive medicine They have more than 15000 products and serve to clinicians over 45 countries

Corporate Office of Confidential has implemented a SAP BW based application called Field Action Reporting System which is used to identify track recall and reconcile products having quality issues Quality reports were generated by the application to inform FDA about product quality issues It was an endtoend application covering business scenarios from raw material receipt to dispatch to customer and return of the product I was involved in preparing technical documentation for enhancement of the application by adding two new modules and also in the change control procedures

Responsibilities



  • Developed Functional Requirements and Systems/Software Requirements from the Business Process Requirements
  • Prepared Requirement Traceability Matrix using DOORS application for linking SSR FRS and Test scripts
  • Carried out risk analysis for two new modules and system changes to existing application
  • Extensively involved in the Change control procedure by identifying priority issues filling out system change request form getting the approvals from the Quality Assurance and Business Owners and updating the technical documents by incorporating the changes
  • Prepared test scripts for testing new modules as well as for changes in the existing modules
  • Developed Operational Qualification and Performance Qualification report for the two new modules
  • Created and updated technical documents and uploaded into Product Data Management the application used at BSC to manage all product documentation throughout product life cycle
  • Updated Project Quality Plan and Risk Analysis documents by incorporating system changes
  • Participated in drafting SOP Work Instructions and Training manual for the new modules


Graduate Research Assistant Confidential

  • Carried out protein assays and used western blot technique to find effect of the research drug on protein synthesis in mammalian cells
  • Identified transitional behavior by using Thermally Stimulated Current technique in Avon proprietary polymers
  • Used strong analytical problem solving and computer data analysis skills to design TSC experiments for Avon polymers to get useful results

Technical Services Engineer Confidential

  • Used SAP R/3 to generate sales and distribution reports
  • Carried out presales and aftersales service activities for industrial customers for petroleum products ie lubricants and petroleum fuels
  • Provided all the required technical support to industrial customers for lubricant application assessing lubricant requirements new/trial grades condition monitoring maintenance planning and troubleshooting
  • Provided technical services with respect to petroleum fuel applications eg Fuel conservation Energy Audit Fuel testing

Shift Process Engineer Confidential

  • Independently oversaw process operations of Marine Tank Farm Utilities section which included Effluent Treatment Plant ETP Air Compressor and Air Drying section and Sea Water Filtration Plant
  • Handled continuous operations including oil water separation filtration chemical mixing aeration flocculation chlorination utilities supply activated carbon treatment and biological waste treatment
  • Used advanced process control technologies including DCS and PLC to maintain process productivity

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