SUMMARY

• Expertise in Design, Configuration, Unit Testing and Deploying Labware LIMS application modules.
• Expertise in implementing interfaces with instruments (like Climet, Metone, Growth Direct) and other external applications
• Experience in Data Migration, Periodic Review, Change Controls, Change Reporting, GAP Analysis, and Risk analysis, CAPA, FMEA and Remediation Process.
• Expertise in resolving and tracking identified IM and PM bugs using HP Service Manager and Service - now application
• Expertise in implementing various complex ELN Templates
• Expertise in designing and implementing reports including crosstab reports and sub-reports using Crystal Reports XI
• Experience in defect identification and implementing using JIRA and tracking deployment using applications such as Bit-Bucket and HPALM
• Experience in requirements analysis process and transforming the client requirements into solutions
• Strong knowledge and experience in developing Design Specification (DS), Installation Verification (IV), Development Summary Report(DSR) and Requirements Traceability Matrix (RTM).
• Expertise in designing and tuning SQL queries and views to improve the performance of the modules
• Experience in implementing the out of box functionalities to archive legacy system data and instrument interfaces to process instrument data
• Expertise in implementing and upgrading multiple complex modules in StarLIMS application.
• Solid understanding and work experience in HAR, GxP, GMP and GLP environments in pharmaceutical and biotechnology industries
• Experience in implementing 21 CFR part 11 annexure 11 guidelines in Laboratory information systems.
• Estimation, Planning, Resource Allocation and Task Prioritization.
• Hands on experience in LabVantage LIMS configurations.
• Through experience in all stages of Software Development Life Cycle (SDLC)
• Supported Validation and Quality Assurance teams in implementing various solutions in the laboratory environment.
• Manage team and Development activities in all test phases and all stages of application software development life cycle (SDLC) using Agile and Waterfall methodologies.
• Skilled professional in communicating with clients and other stakeholders to meet project timelines and evaluate progress while assuring smooth, efficient project activities.

PROFESSIONAL EXPERIENCE

Confidential, Bay Area, CA

Subject Matter Expert

Responsibilities:

• Gathering requirements from stakeholders, documenting story points in JIRA, preparing Functional Specifications, Design Specifications and Implementing the requirements.
• Expertise in writing complex code using LIMS Basic across sub-routines, menu routines and other Labware objects
• Expertise in creating customized functionalities including User Dialogs, Access Routines and Visual Workflows in Labware LIMS
• Implemented Environmental Monitoring (EM) module and interfaced successfully with various modules of Labware.
• Implemented interfaces between Labware and Climet, Metone, Growth Direct instruments
• Integrated Labware LIMS with CORAL (Java based application) for R&D labs using MuleSoft as middleware
• Worked on extensive enhancements to STABILITY module in Labware across various sites in US, Europe and Asia Pacific
• Implemented and updated Routine and Non-Routine Quality Control modules in Labware
• Experience on enhancements to Product Testing module in Labware LIMS
• Expertise in creating and deploying the packages using Configuration Manager module
• Categorised the complexity and priority of the enhancements, provided estimates and allocated resources based on the development task prioritization
• Leveraged offshore team to develop the application modules in a cost effective way
• Have experience in working in a Managed Services environment
• Helped management team in preparing estimates of medium to large projects
• Provided daily status reports, weekly status reports to the management team and stake holders regularly
• Managed and mentored team members to bring them up to speed in the fast paced work environment
• Performed peer reviews of code for coding standards, best practices, functionality and error handling
• Gathering requirements from stakeholders and site SMEs
• Architected design and workflows for LIMS - instrument interface
• Installed and configured Growth Direct instrument and relative Bridge computer
• Setup Master Data including Sample Login Templates, Analysis, Batch Test Templates, Application Events, Schedulers
• Developed Menu Routines, Subroutines and Schedulers to send Requests to Growth Direct instrument and to parse results into LIMS from Growth Direct instrument
• Configured Growth Direct interface to Product Testing (PT) and Environmental Monitoring (EM) modules
• Architected design and workflows for CORAL - LIMS integration/automation
• Designed .json object and xml structures to communicate between CORAL-Mulesoft-LIMS applications
• Implemented partial code objects in CORAL (Java based application) to generate .json object and communicate with Mulesoft
• Updated database structure to receive and send communications to CORAL and Mulesoft, implemented database views to access LIMS data
• Automated the process of creating/updating Projects, Sample Login by implemented Schedulers/Subroutines and communicate with Mulesoft
• Designed various error handlings at different stages of the workflow