QC Lab Support

CSL • Kankakee, IL

1d • $87,000 - $102,000

About The Position

The QC Lab Support Analyst is responsible for the day-to-day operational support, configuration, compliance, and lifecycle sustainment of Quality Control (QC) laboratory computerized systems at the site. Reporting to the Automation Site Head, this role ensures reliable and compliant operation of lab OT applications including LIMS, LES, CDS, instrument software, and associated infrastructure supporting QC testing. The role provides hands-on technical and compliance support to QC laboratories by executing incident management, system administration, validation support, and continuous improvement activities in alignment with GxP, data integrity, and global Engineering and Maintenance standards. Through close collaboration with QC, Quality, CSV, I&T, and external vendors, the QC Lab Support Analyst ensures lab systems remain inspection-ready, performant, and aligned with site manufacturing needs. Role that this position reports to: Automation Site Head Role/s that report to this position: Individual Contributor

Requirements

• Bachelor of Science (BS) degree in engineering, Computer Science, or a relevant scientific discipline (Chemistry, Biology, Microbiology, etc.); advanced degree preferred.
• 3–6+ years of experience supporting QC lab computerized systems in a regulated environment.
• Hands-on experience with LIMS, LES, CDS, or lab instrument software.
• Experience in GxP environments with strong understanding of data integrity principles.
• Experience supporting CSV activities and validation documentation.
• Familiarity with Windows server environments, virtualization, and backups preferred.
• Experience working with QC laboratories in pharmaceutical or biotech manufacturing.
• Ability to work cross-functionally with Quality, Automation, I&T, and lab users.
• QC Lab Systems Expertise
• GxP Compliance & Data Integrity
• Computer System Validation Support
• Technical Troubleshooting
• Instrument System Support
• Change Management Discipline
• Continuous Improvement
• Stakeholder Collaboration
• Documentation & Inspection Readiness

Responsibilities

• QC Lab Systems Operational Support Provide day-to-day support for QC computerized lab systems including LIMS, LES, CDS (e.g., Empower, Chromeleon), and instrument applications. Troubleshoot hardware, software, and network-related issues affecting QC lab systems. Manage incident prioritization and resolution in coordination with QC lab stakeholders. Engage vendors and support teams for timely service restoration. Ensure systems maintain high availability supporting QC testing operations.
• System Administration and Technical Sustainment Perform system administration activities including user access, role configuration, and environment support. Support validated servers, virtual environments (VMware/Citrix where applicable), backups, and system health monitoring. Install software releases, patches, and upgrades in accordance with change control. Maintain GMP data servers and support data retrieval and reporting needs. Coordinate with local I&T on infrastructure reliability and cybersecurity requirements.
• Validation, Compliance, and Data Integrity Support Computer System Validation (CSV) activities including IQ/OQ/PQ execution and documentation. Prepare and maintain validation deliverables, SOPs, periodic reviews, and audit trail assessments. Ensure systems comply with GAMP 5, 21 CFR Part 11, Annex 11, CSL Global E&M and quality standards. Support inspections, audits, deviations, and CAPAs related to lab systems. Execute periodic reviews, user access reviews, and system compliance monitoring.
• Lab Instrument and Interface Support Support onboarding, configuration, and sustainment of laboratory instrument software. Assist with instrument / system interfaces and data flow validation. Support IQ/OQ/PQ activities for new lab instruments and software. Ensure reliable and compliant data transfer between instruments and enterprise systems. Collaborate with Automation, QC, I&T and vendors during instrument deployments.
• Change Management, Investigations, and Continuous Improvement Support risk assessments, change controls, and system enhancements. Participate in investigations, deviations, and CAPAs. Identify opportunities to improve system reliability, performance, and standardization. Assist in implementing new features, tools, or technologies that enhance QC lab efficiency. Contribute to harmonization of lab system practices across the site.
• User Support, Documentation, and Stakeholder Engagement Provide front-line technical support to QC laboratory users. Develop and maintain technical documentation, SOPs, and support materials. Collaborate closely with QC Lab Management, Quality, CSV, Automation, and I&T. Support user training and onboarding for lab systems. Communicate system status, risks, and improvement opportunities to site leadership.
• Supplier, Partner, and Technology Ecosystem Management Oversee local system integrators, OEMs, and service partners, ensuring adherence to GMP, safety, and performance standards in alignment Global E&M and QC strategic partnerships. Evaluate and monitor vendor work packages, deliverables, and documentation for compliance and quality. Drive efficiency, cost control, and innovation through structured partner engagement and performance reviews.
• Site OT Roadmap, Continuous Improvement, and CoE Support Contribute to the site automation and digital roadmap, aligned with the global Engineering & Maintenance, and QC strategy. Actively contribute to the global OT Center of Excellence (CoE) by sharing best practices, lessons learned, and site performance data. Implement enterprise standards, templates, and architectures within site OT systems, ensuring harmonization and scalability. Monitor KPIs for system uptime, performance, and digital maturity; report progress to site and global leadership.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 1,001-5,000 employees