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LIMS Subject Matter Expert

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LIMS Subject Matter Expert (SME) Opportunity – Seattle, WAMy client is seeking a LIMS Subject Matter Expert (SME) to join a global biotech company located near Seattle, Washington. The role will involve ownership of project management for LIMS, including data entry into the system and managing any associated procedural revisions.Role ResponsibilitiesSystem Implementation & ConfigurationLead requirements gathering from QC, R&D, and Manufacturing laboratoriesConfigure LIMS workflows for sample management, stability studies, batch release, and analytical testingIntegrate LIMS with laboratory instruments (HPLC, GC, LC-MS) and enterprise systems (ERP, MES, ELN)Validation & ComplianceDevelop and execute Computer System Validation (CSV) protocols (IQ/OQ/PQ)Ensure compliance with 21 CFR Part 11, GAMP 5, and Annex 11Maintain audit trails, electronic signatures, and secure user accessTraining & SupportDeliver training to laboratory staff and system administratorsProvide ongoing support for troubleshooting, upgrades, and change managementIf this opportunity may be of interest, please let me know. Alternatively, referrals are welcome if you know someone who may be a good fit.