QC Informatics Specialist

Job Title: QC Informatics Specialist Location: Louisville, CO

Experience: 5 - 8 Years

Overview The QC Informatics Specialist plays a key role in supporting pharmaceutical and biopharmaceutical clients by ensuring the quality, compliance, and reliability of QC Informatics and infrastructure. This role provides hands-on exposure to lab operations, system validation, IT maintenance, and Quality Assurance oversight. The position works closely with Quality, Lab Management, and Project Managers to maintain regulatory compliance and ensure smooth operation of critical lab systems.

Key Responsibilities

Lead GxP IT QC activities in line with validation plans and regulatory requirements (cGxPs, GAMP 5, 21 CFR Part 11, EU Annex 11).

Draft, review, and approve Validation Life Cycle (VLC) documents, test scripts, and deviations.

Support audits and inspections related to validated laboratory systems.

Contribute to quality programs including Data Integrity, Training, Deviations, and Change Control.

Maintain IT and laboratory policies and procedures, including cybersecurity, patch management, and system administration.

Provide in-person troubleshooting for lab hardware (PCs, analyzers, access issues, resets).

Administer and support GxP systems such as LIMS, NuGenesis, ELN, QMS, Deltek, Microsoft Office/SharePoint, and e-signature platforms.

Oversee onboarding/offboarding for systems, hardware, and facility access.

Manage server and cloud monitoring, software updates, licensing, and IT budget tracking.

Conduct vulnerability assessments and penetration tests, and manage remediation activities.

Support automation and reporting initiatives using tools like PowerApps and Power BI.

Follow all laboratory and safety policies and procedures.

Qualifications

• Bachelor’s degree in a science or technical field, or equivalent experience.

• Minimum 5 years of IT and/or QC experience in regulated industries (pharma, biotech).

• Strong knowledge of GMP, GLP, FDA regulations, 21 CFR Part 11, EU Annex 11, GAMP 5, and data integrity principles.

• Experience with validation lifecycle documentation, risk management (ICH Q9), and GxP systems.

• Hands-on IT skills including hardware troubleshooting, Microsoft Office, SharePoint, and laboratory informatics systems.

• Excellent analytical, communication, and interpersonal skills.

• Ability to work independently as well as collaboratively in team settings.

• Strong organizational skills with the ability to handle multiple projects simultaneously.