GxP QC IT Analyst: Validation & Support

USDM Life Sciences; Lexington (MA); Remote; USD 96,000 - 110,000; Full time

Job summary

USDM Life Sciences is seeking a QC IT Application Analyst to support GMP QC IT operations, including validation activities, access reviews, and audit trail reviews. You will also provide front-line client support and oversee vendor solutions in a Windows environment, using Veeva, TrackWise, and ServiceNow.

The role requires a Bachelor’s degree in Computer Science or Information Systems, familiarity with CSV and 21 CFR Part 11, and experience in ITIL processes.

Qualifications

• Bachelor’s degree in Computer Science or Information Systems or related field if preferred.
• Experience with Computerized Systems Validation (CSV), 21 CFR Part 11 regulations, and Data Integrity compliance.
• Experience working with ITIL processes in ServiceNow such as Incident Management, Change Management, Problem Management, Asset and Configuration Management (CMDB).

Responsibilities

• Collaborates with the business and IT teams to provide project support for MA Biologics Operations Site Functions – Quality, Validation and Product Development.
• Provide oversight of vendor-provided solutions.
• Handle ad-hoc technical requests from internal and external partners in accordance with projects assigned.
• Work with Direct team members for decisions and clarifications as needed.
• Must be able to juggle multiple projects and split billing time between projects where needed.
• Experience with design testing of applications to help author SDLC documents.

Skills

Veeva

TrackWise

ServiceNow

Windows

Word

Excel

Education

Bachelor's degree in Computer Science or Information Systems

Tools

MS Office 365

MS Visio

MS Project

Citrix

SQL Databases

LDAP

Group Policy

TCP/IP Networks

Server Virtualization

RDP

Backup and Restore

Job description

USDM Life Sciences is seeking a QC IT Application Analyst to support GMP QC IT operations, including validation activities, access reviews, and audit trail reviews. You will also provide front-line client support and oversee vendor solutions in a Windows environment, using Veeva, TrackWise, and ServiceNow.

The role requires a Bachelor’s degree in Computer Science or Information Systems, familiarity with CSV and 21 CFR Part 11, and experience in ITIL processes.