QC IT Application Analyst

Katalyst Talent Agency

Lexington, MA, United States

2 days ago

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Role details

Contract type

Permanent contract

Employment type

Full-time (> 32 hours)

Experience level

Expert

Experience required

5 years minimum

Compensation

$90,000.0 - $135,000.0

Working hours

Regular working hours

Job source

www.careerjet.com

Tech stack

Microsoft Windows Active Directory Software Applications Audit Trail Data Integrity Information Technology Operations NT File System (NTFS) Systems Development Life Cycle Chromeleon Product Software Implementation Methods System Testing Trackwise

+3 more

Veeva GXP Servicenow

Job description

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).

Requirements

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).

Benefits & conditions

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