Sr. Quality Systems IT Administrator

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Full Time Professional Woodstock, IL, US

Salary Range: $ To $ Annually

The Sr. IT Systems Administrator – Quality is responsible for supporting, maintaining, and improving Quality (including laboratory) software-controlled systems across the facility. This role owns the full lifecycle of assigned applications — configuration, development, installation, deployment, and ongoing maintenance of the application, database, configuration, and licensing — and serves as a primary technical contact for server and system changes, Active Directory, updates, backups, validated-system support, and troubleshooting of systems that directly impact quality operations.

This position helps ensure key quality/laboratory and compliance systems remain available, reliable, secure, current, and compliant with cGMP, FDA, and computerized system validation (CSV) requirements, while supporting upgrades, audit-trail and access reviews, SOPs, CAPA, vendor coordination, risk management, and continuous improvement. As Woodstock is a 24/7 operation, this position will at times require technical support remotely and/or onsite outside of normal office hours.

• Own the full lifecycle of assigned applications — configure, develop, install, deploy, and maintain the application, database, configuration, and licensing. (Standard desktop productivity software such as Microsoft Office, Visio, and Project is excluded and managed by the IT infrastructure/operations team.)
• Provide application administration and validated-system support for software-controlled systems — including but not limited to Master Control, LabX, Empower, NuGenesis, and other quality/laboratory instrument data systems — including onboarding new products, methods, and reporting templates, and adding or removing instruments in coordination with the IT team.
• Routinely monitor application and data-system health using checklists, logs, alerts, and monitoring tools, and lead debugging and troubleshooting of application issues, escalating infrastructure-level issues to the appropriate IT teams.
• Serve as the primary technical point of contact, with the IT infrastructure team, for server or system changes affecting quality operations (e.g., Active Directory, server/software updates, IP address changes, backups); coordinate and validate quality impact, but do not perform Server OS, hardware, or VM administration.
• Manage all user access to assigned applications and perform the required user, access-log, and audit-trail reviews for GxP-relevant systems.
• Verify that backup and restore procedures are properly configured and functional (e.g., database dumps, Veeam/Commvault) and maintain readiness to restore primary applications following a disaster.
• Maintain complete application documentation — workflow diagrams, baseline and current configuration, operating procedures/SOPs, scope, requirements, purchase, licensing, maintenance, and technical-support records.
• Manage vendor relationships for assigned applications and equipment, including support contracts, maintenance agreements, upgrades, and project deliverables.
• Support the full computerized system validation lifecycle (IQ/OQ/PQ) and adhere to change control for all application changes — including impact assessment, documentation, validation/revalidation, and CAPA execution with effectiveness verification.
• Perform periodic system analysis and drive upgrades and process improvements; contribute to a multi-year roadmap addressing technical debt and system/equipment…