Lead QC Systems Analyst, Quality Control

Key Responsibilities

• Serve as the QC lead and QC administrator for LabWare LIMS and MODA, providing guidance for QC-owned configurations, workflows, master data, and system use.
• Lead the creation, review, approval, and maintenance of master data, including products, item codes, methods, specifications, stability protocols, sample plans, and related QC testing workflows.
• Provide advanced support to QC end users, including account and role management, complex troubleshooting, issue triage, training, and escalation coordination.
• Lead testing, maintenance, and updates for existing LIMS and MODA modules to ensure system performance, data integrity, usability, and GMP compliance.
• Lead or support implementation of new system modules, enhancements, integrations, and workflow improvements in collaboration with IT, QA, Validation, Manufacturing, and system vendors.
• Translate QC business needs into clear functional requirements, process flows, configuration expectations, and testable system outcomes.
• Document functional requirements, process flows, configuration changes, impact assessments, and supporting rationale in accordance with change control and data integrity requirements.
• Lead system testing activities, including development and review of test plans, test scripts, expected results, discrepancy resolution, and evaluation of testing outcomes.
• Support validation activities by reviewing validation deliverables, supporting protocol execution, assessing deviations, and ensuring QC requirements are appropriately represented.
• Develop, revise, and maintain SOPs, work instructions, job aids, and training materials related to QC administration and use of LIMS and MODA.
• Provide training, coaching, and mentoring to QC users, process owners, and junior analysts to ensure consistent and compliant system use.
• Identify system issues, design gaps, data integrity risks, and process inefficiencies, and lead the development of compliant, practical solutions.
• Support audits and inspections by providing system knowledge, documentation, traceability, and SME support for QC electronic systems.
• Lead or participate in continuous improvement initiatives related to QC electronic systems, master data governance, workflow efficiency, and inspection readiness.
• Partner with QC leadership to prioritize system requests, evaluate business impact, and support long-term LIMS/MODA roadmap planning.

Minimum Qualifications

• Bachelor’s degree in Life Sciences, Computer Science, Information Systems, or a related discipline plus 8–10 years of Quality Control experience in a GMP-regulated biotechnology, pharmaceutical, or medical device environment is required.
• A minimum of 1-2 years of experience supporting LIMS, MODA, or similar laboratory electronic systems is also required.
• QC laboratory experience is required so that testing workflows, sample management, data review expectations, stability, lot release, and GMP compliance requirements can be appropriately applied to LIMS configuration, master data governance, troubleshooting, and process improvement.