Lab Equipment Business Analyst

Position : Lab Equipment Business AnalsytLocation: Cambridge MACore RequirementsExcellent lab equipment implementation and validation documentation skills in a GxP lab environmentWorking on and validating lab equipment, for example, NC-200, XURI (Unicorn), Met One, BACT/MYLA, FACSDiva, etc Authoring and managing the end-to-end process for creating GxP validation plansAuthoring GXP validation documentation such as User Requirements Specs, System Design and Configuration Specs, IQ/OQ Test Packages, Traceability Matrices, Test/Validation Summary reports and SOPs, including IT System Administration GuidesInterfacing and liaising between all levels of IT, business and third-party vendorsGathering and managing business requirements,Writing test scripts, testing software (UAT, IQ, OQ), through ALM and/or manually, writing the test report and shepherd approvals through the approval processUnderstanding of key concepts and principles of data integrity and hands on experience with data management and IT audit trail reviewsWith lab systems nice to haveExpertise in CFR Part 11/GxP software qualification.Understanding of data management for GxP lab equipmentAssist in managing data integrity across lab equipment and systems, as well as enterprise systemsData resiliency – backup, restore, archiveAudit trail review and managementPerforming annual account reviews, periodic reviewsAssisting GMP data quality assessments and managing deviationsWorking knowledge of data archiving and electronic document management systems; prefer experience with OpenLab and Veeva Quality Doc to manage backup and restore processes