LIMS Data Specialist

Job Title: LIMS Data Specialist Location: St. Louis MO 63118 (Hybrid) Duration:12 Months Contract Shift: Day shift Job Summary We are seeking a detail-oriented and motivated LIMS Data Specialist. The role involves managing product and master data within the Laboratory Information Management System (LIMS), ensuring compliance with regulatory requirements such as 21 CFR Part 11 and EU Annex 11, and maintaining high standards of data integrity. Key Responsibilities • Create, review, and approve product and master data builds in LIMS in compliance with regulatory guidelines. • Ensure adherence to 21 CFR Part 11 and EU Annex 11 requirements, with a strong focus on data integrity. • Support QC and QA operational activities by prioritizing and managing data-related tasks. • Review, update, and revise documentation as required. • Act as a LIMS system administrator, including: • Managing user accounts, roles, and access controls • Supporting system configuration and maintenance • Assist in defining and improving QC workflow integration within LIMS. • Support deviation investigations and implement corrective actions as needed. • Manage and execute change control processes using TrackWise. • Collaborate cross-functionally with laboratory, QA, and IT teams. Qualifications • Bachelor’s or Master’s degree (BS/BA or MS) in Life Sciences or a related field. Experience Requirements • 3–5 years of GMP experience in the pharmaceutical, biopharmaceutical, or chemical industry. • Hands-on experience with LIMS (LabVantage preferred). • Experience with analytical and/or instrumentation testing is preferred. • Prior data entry and data management experience. • Familiarity with laboratory instrumentation and documentation practices. • Experience with Track Wise or similar change control systems is a plus.