The LIMS Master Data Specialist is responsible for the creation, modification, maintenance, and verification of LIMS master data objects within LabWare. Working within the governance framework defined by the master data governance council, the Specialist handles requests from operational teams (analytical development and QC), executes master data builds for new products or methods, and serves as a subject matter expert (SME) for LIMS data during audits and operational troubleshooting.
Responsibilities
- Create and maintain LIMS master data, including test definitions, specifications, workflows, calculations, and sample structures
- Assess impacts of master data changes, perform testing, approvals, and controlled migrations
- Maintain version history, traceability, and conduct regular data quality reviews
- Process QC requests and prepare GxP-compliant documentation, change records, and validation test scripts
- Support CSV activities, audits, and ensure compliance with ALCOA+, 21 CFR Part 11, and EU Annex 11 requirements
- Act as first contact for QC master data issues and troubleshooting
- Collaborate with QC scientists to implement analytical methods in LIMS
- Support product introductions, specification updates, method transfers, and LIMS 7→8 migration activities
Qualifications
- Strong experience with LabWare LIMS configuration, master data maintenance, workflow templates, and calculation scripting review
- Understanding of LIMS Basic scripting, SQL (preferred), Crystal Reports, ELN templates, and system interfaces (ERP/instrument integration)
- Knowledge of pharmaceutical QC workflows, analytical testing, and master data governance
- Ability to interpret analytical methods and translate them into structured LIMS configurations
- Detail-oriented, organized, and effective in managing multiple priorities with strong written communication and collaboration skills
- 3–6 years in QC, analytical development, regulatory, or laboratory informatics, including 1–2 years of direct LabWare LIMS configuration or master data management experience
