GxP IT Application Analyst: QC Systems & Validation

Intellibee Inc; Lexington (KY); On-site; USD 85,000 - 120,000; Full time

Job summary

Intellibee Inc. is seeking a QC IT Application Analyst in Lexington, MA to support GMP operations within Quality, Validation and Product Development functions. You will coordinate program upgrades, manage vendor solutions, and assist with SDLC documentation and GxP compliance.

The role requires strong IT/business analysis experience, proficiency with ServiceNow, TrackWise, Veeva, and active directory permissions, and the ability to juggle multiple projects in a global matrix environment.

Qualifications

• Over 5 years of IT/business experience with documenting requirements (required).
• Experience with software implementations in a GxP environment (required).
• Bachelor's degree or equivalent in IT/CS/Engineering/Business.
• Pharma/Life Sciences experience preferred.
• Experience in a complex global matrix organization preferred.
• Knowledge of Lean operational techniques preferred.

Responsibilities

• Support QCIT operations in a GMP environment, including backups, restores, access reviews, and audit trails.
• Provide front-line client support and triage for systems downtime.
• Support GxP workstation patching and decommissioning activities.
• Manage upgrades (e.g., Windows 7 to Windows 10) and oversight of vendor-provided solutions.
• Collaborate with IT and business teams and assist with SDLC documentation (SDLC, URS, FRA, IQ/OQ, etc.).

Skills

ServiceNow

Veeva

TrackWise

Active Directory

NTFS permissions

User access reviews

SDLC documentation

GxP compliance

ITIL processes

Lab equipment knowledge

Education

Bachelor's degree in IT/CS/Engineering/Business

GxP/Life Sciences experience

Pharma/biotech industry exposure

Tools

Empower

Chromeleon

SOLO VPE

GE Unicorn

Nova Biomed Bioprofile CDV

Roche Cedex

DataPro2

WinKQCL

LabX

Bartender

My Access

ViCell

Waters Alliance

Job description

Intellibee Inc. is seeking a QC IT Application Analyst in Lexington, MA to support GMP operations within Quality, Validation and Product Development functions. You will coordinate program upgrades, manage vendor solutions, and assist with SDLC documentation and GxP compliance.

The role requires strong IT/business analysis experience, proficiency with ServiceNow, TrackWise, Veeva, and active directory permissions, and the ability to juggle multiple projects in a global matrix environment.