LIMS Analyst

LIMS (LabVantage) Analyst 12-month Contract Remote- EST Hours

Requirements

• Support the implementation of the LabVantage Laboratory Information Management System (LIMS) by supporting the Quality Control (QC) department during User Acceptance Testing (UAT), master data review, and data migration activities.
• Gain working knowledge of QC processes, LIMS functionality, and workflows.
• Review business requirements, system documentation, and LIMS processes.
• Partner with business SMEs, Quality, and IT teams to support implementation activities.
• Execute, document, and maintain UAT test scripts and test cases.
• Verify system functionality against business requirements.
• Support resolution of system defects and participate in regression testing and test readiness activities.
• Coordinate testing activities with business stakeholders.
• Review and verify master data, including products, specifications, test methods, materials, users, and laboratory workflows.
• Identify data gaps, inconsistencies, and process improvement opportunities.
• Support development and maintenance of master data governance processes.
• Monitor data migration activities from legacy LabWare LIMS.
• Review migrated data for accuracy, completeness, and integrity.
• Perform data reconciliation and support business acceptance of migrated data.
• Document and track data-related issues through resolution.
• Transition into the Business Administrator role for the LIMS platform.
• Manage user access, roles, and permissions.
• Support master data maintenance and business configuration activities.
• Maintain business procedures, training materials, and system documentation.
• Serve as the primary business contact for day-to-day LIMS support and enhancement requests.
• Support inspections, audits, and compliance-related activities.
• Support go-live readiness and post-implementation activities.
• Develop and maintain UAT execution and testing documentation, master data review and verification reports, data migration verification and reconciliation documentation, and business administration procedures and user support documentation.

Qualifications

• Bachelor’s degree in Chemistry, Biology, Microbiology, Biochemistry, Pharmaceutical Sciences, or a related scientific discipline.
• Minimum 3–5 years of Quality Control (QC) laboratory experience in a pharmaceutical, biotechnology, cell therapy, gene therapy, or other regulated GMP environment.
• Hands-on experience with QC laboratory operations, including sample management, testing workflows, specifications, investigations, stability programs, and data review.
• Experience working with Laboratory Information Management Systems (LIMS), such as LabVantage, LabWare, STARLIMS, SampleManager, or equivalent laboratory systems.
• Experience supporting system implementations, User Acceptance Testing (UAT), validation, or process improvement initiatives.
• Knowledge of GMP, GxP, ALCOA data integrity principles, and regulatory requirements applicable to laboratory systems.
• Experience reviewing and managing laboratory master data, including products, specifications, test methods, materials, and user roles.
• Strong analytical, problem-solving, organizational, communication, and documentation skills.
• Previous experience serving as a LIMS Business Administrator, Super User, or System Owner preferred.
• Previous experience with LabVantage LIMS preferred.
• Experience supporting LIMS implementation, upgrade, or deployment projects preferred.
• Experience developing and maintaining end-user guidance documents preferred.
• Experience with master data management and data migration activities in LIMS preferred.