QC Lab CSV - Liz - Abbvie

Role Overview

We are seeking a skilled Lab IT & Equipment Support Analyst to provide end‑to‑end support for QC laboratory systems and equipment. The role combines Computer System Validation (CSV), IT system administration, and hands‑on lab equipment support, ensuring compliance with GxP standards and smooth QC operations

Key Responsibilities

• Administer and support QC Lab IT systems (Empower, LIMS, ELN, EMS, and other GxP‑compliant applications).
• Provide technical support for laboratory equipment including installation, configuration, troubleshooting, calibration, and preventive maintenance.
• Execute CSV activities (IQ/OQ/PQ, test planning, execution, and documentation) for lab systems and benchtop instruments.
• Manage user access, roles, and Active Directory accounts in compliance with audit requirements.
• Collaborate with QA, QC, Validation, and Engineering teams to ensure operational readiness and compliance.
• Support regulatory audits (FDA 21 CFR Part 11, EU Annex 11, NPRA, ISO) and maintain accurate SOPs, configuration specifications, and validation reports.
• Conduct incident troubleshooting and root cause analysis for both IT systems and lab equipment.
• Provide end‑user training on lab IT systems, CSV procedures, and equipment usage.
• Track and manage software licenses, patches, updates, and IT asset inventory.

equired Skills & Expertise

• Strong knowledge of GxP, FDA 21 CFR 11, EU Annex 11, and GAMP5 compliance.
• Hands‑on experience with QC lab equipment support and IT system administration.
• Proficiency in CSV execution, documentation, and performance qualification.
• Familiarity with development methodologies (Waterfall, Agile).
• Analytical thinking, attention to detail, and strong problem‑solving skills.
• Excellent communication and collaboration across cross‑functional teams.