QC Lab Systems Analyst

Job Description

Design, configure, integrate, and support QC laboratory systems, including LIMS, chromatography data systems, and instrument integrations, while ensuring reliable operations and timely batch release. Lead system validation, compliance, lifecycle management, complex issue resolution, continuous improvement, and technical mentoring for the site’s lab systems workstreams.

Requirements: A bachelor’s degree in a relevant technical or scientific field and at least five years of experience implementing or supporting QC laboratory systems in a GMP-regulated industry are required. Candidates need hands-on experience with a commercial LIMS or CDS, knowledge of regulatory and data-integrity requirements, and a strong understanding of QC laboratory processes; a master’s degree and experience with the listed platforms and integrations are preferred.

Key Skills: LIMS Configuration and Support, Chromatography Data Systems, Laboratory Instrument Integration, Computer System Validation, GMP Compliance, Data Integrity, QC Laboratory Workflows, System Lifecycle Management, Incident and Change Management, Root Cause Analysis, Risk-Based Validation, Technical Leadership and Mentoring, Stakeholder Collaboration, SQL, Python, Cybersecurity

Benefits: Company Bonus, 401(k), Pension, Vacation Benefits, Medical Insurance, Dental Insurance, Vision Insurance, Prescription Drug Benefits, Flexible Spending Accounts, Life Insurance, Death Benefits, Leave Benefits, Employee Assistance Program, Fitness Benefits, Employee Clubs and Activities