LIMS Master Data Specialist III

Hartmann Young are currently partnered with a well known, global contract development manufacturing organisation (CDMO), who are looking to expand their team in New York.

Role overview:

• Create and revise master data elements in the LIMS platform, including test methods, specifications, analytical procedures, sampling plans, product parameters, and instrument mapping.
• Enforce data integrity standards, version control, and data accuracy across all laboratory processes. Ensure compliance with global corporate policies and regulatory standards (e.g., FDA 21 CFR Part 11, cGMP, ISO 17025.)
• Partner with lab subject matter experts (SMEs) to gather business requirements and map existing workflows to system capabilities. Partner with IT System Admin to develop, test and implement new functionality.
• Serve as the first line of support for end-user issues, troubleshoot master data anomalies, and assist with data migration during system upgrades. Support routine troubleshooting of data-related issues and elevate technical problems to System Admin or vendor as needed.
• Own and update Master Data Standard Operating Procedures (SOPs), data maps, and validation documentation associated with LIMS.
• Build and maintain test definitions, sampling plans, specifications, and stability protocols in LIMS, in collaboration with QC SMEs.
• Work closely with IT, QA, and QC leadership to test system settings, user roles, and permissions.
• Support internal and external regulatory audits and inspections by providing LIMS documentation and system access as required.
• Execute validation test scripts associated with LIMS.
• Work with QC leadership to support ongoing LIMS improvements and upgrades.

Requirements:

• Associate’s or Bachelor’s degree in in Life Sciences, Engineering, or a related STEM field.
• Minimum of 2–5 years of experience in a GMP-regulated pharmaceutical or life sciences laboratory environment.
• Experience with LIMS platforms as an end user and/or participation in an LIMS implementation.
• Understanding of analytical testing and techniques

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