QC IT Application Analyst

JobDiva, Inc.; Lexington (MA); On-site; USD 100,000 - 150,000; Full time

Job summary

JobDiva, Inc. in Lexington, MA seeks an IT/Business Analysis professional to support GMP/GxP IT operations, CSV testing, and periodic reviews ensuring data integrity and 21 CFR Part 11 compliance.

Responsibilities include front-line support, decommissioning, and authoring validation artifacts (URS, FRA, IQ, IOQ, ATR) for lab systems and instruments.

Qualifications

• 5+ years IT/Business Analysis experience in GxP/pharma environments.
• Lab software familiarity with GxP desktop tools is preferred.
• Bachelor's degree in IT, CS, Engineering, or Business Administration (or equivalent).

Responsibilities

• Support QC IT operations, CSV periodic reviews, and GxP workstation patching.
• Triage system downtime, coordinate vendor repairs, and manage Windows OS upgrades.
• Author and execute SDLC validation artifacts (URS, FRA, IQ, IOQ, ATR, SOPs) per 21 CFR Part 11.
• Provide technical oversight for lab software and instrument support.

Skills

IT/Business Analysis

Education

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

Tools

ServiceNow

TrackWise

Veeva

Active Directory

MyAccess

NTFS permissions

Empower

Chromeleon

LabX

WinKQCL

Job description

Key Responsibilities:

• GMP / GxP Operations: Support Quality Control IT operations, computer system validation (CSV) periodic reviews (backup/restore testing, user access, audit trails), and GxP workstation patching.
• Front-Line Support & Decommissioning: Provide triage for system downtime, coordinate vendor repairs, handle Windows 7 to 10 upgrades, and perform system decommissioning (account deactivations, final backups).
• Documentation & Testing: Author and execute SDLC validation artifacts (URS, FRA, IQ, IOQ, ATR, Admin SOPs, Data Flow diagrams) adhering to 21 CFR Part 11 and Data Integrity compliance.
• Lab Instrument Support: Provide technical oversight and application support for lab equipment (e.g., Vaya Raman, 7500 Fast PCR, Hiac Particle Counters, Maldi-TOF, Vi-Cell, Antaris II, Waters Alliance).

Education and Experience:

• Experience: 5+ years of IT/Business Analysis experience supporting software implementations in GxP/Pharmaceutical environments.
• Key Tools & Systems: ServiceNow (Incident/Change/Problem), TrackWise (CAPA, Deviations), Veeva, Active Directory, MyAccess, and NTFS permissions.
• Lab Software Knowledge: Empower, Chromeleon, LabX, WinKQCL, or related GxP laboratory desktop software.
• Education: Bachelor's degree in IT, CS, Engineering, or Business Administration (or equivalent).