Senior Quality IT Systems Admin – GMP/CSV Expert

Woodstock Sterile Solutions; Woodstock (IL); On-site; USD 108,000 - 118,000; Full time

Job summary

Woodstock Sterile Solutions in Woodstock, IL is hiring a Sr. Quality Systems IT Administrator to support quality software across the facility. You will own application lifecycle, validation, and audit readiness, interfacing with QA, IT, and production to ensure compliant operations.

The role requires 5–7 years in quality data systems within a cGMP environment, familiarity with Empower, LabX, MasterControl, and a solid command of SQL and validation processes.

Qualifications

• Minimum 5 years in quality data systems in a regulated environment.
• Experience with CSV, GAMP, 21 CFR Part 11 compliance and audits.
• Proven ability to validate systems (IQ/OQ/PQ) and manage risk.

Responsibilities

• Own full lifecycle of quality software applications and data systems.
• Maintain validated-system support and audit-trail readiness.
• Coordinate access control, backups, and disaster recovery.
• Support internal and external audits (FDA, customers).
• Collaborate with IT, QA, and production teams to improve systems.
• Develop and maintain SOPs, documentation, and validation protocols.

Skills

Quality data systems

SQL databases

Regulatory compliance

CSV/21 CFR 11

System validation

LIMS familiarity

Server/VM administration

Documentation & SOPs

Education

Bachelor's degree in IT or related

Master's degree a plus

Tools

Waters Empower

Waters NuGenesis

LabX

MasterControl

Veeam

Commvault

Active Directory

Job description

Woodstock Sterile Solutions in Woodstock, IL is hiring a Sr. Quality Systems IT Administrator to support quality software across the facility. You will own application lifecycle, validation, and audit readiness, interfacing with QA, IT, and production to ensure compliant operations.

The role requires 5–7 years in quality data systems within a cGMP environment, familiarity with Empower, LabX, MasterControl, and a solid command of SQL and validation processes.