QC IT Application Analyst

Role Overview

We are seeking a QC IT Application Analyst to support client Quality Control (QC) operations in a GMP environment. This role provides critical project support for MA Biologics Operations Site Functions and manages application validation, system upgrades, vendor solutions, and front-line technical support.

Key Responsibilities

• Developing and executing periodic validation activities (backup/restore testing, user access reviews, audit trail reviews).
• Providing front-line client support for triage during system outages.
• Supporting GxP workstation patching and decommissioning activities.
• Collaborating with business and IT teams to deliver project support for Quality, Validation, and Product Development functions.
• Managing project upgrades (e.g., Windows 7-10), overseeing vendor solutions, and handling ad-hoc technical requests.

Required Skills & Experience

• Perform design testing to author SDLC documents including SDCS, URS, FRA, Admin SOPs, IQ/OQ/ATR, and Data Flow diagrams.
• Strong proficiency in Word and Excel within a Windows environment for document management.
• Demonstrated experience with Computerized Systems Validation (CSV), 21 CFR Part 11 regulations, and Data Integrity compliance.
• Familiarity with ITIL processes via ServiceNow (Incident, Change, Problem Management) and Asset/Configuration Management.
• Experience with TrackWise (CAPA, Deviation, Change Control) and Veeva Document Workflows.