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QC IT Application Analyst
Job in
Lexington, Middlesex County, Massachusetts, 02173, USA
Listed on 2026-10-05
Listing for:
JobDiva, Inc.
Full Time
position Listed on 2026-10-05
Job specializations:
-
IT/Tech
IT Support
Job Description & How to Apply Below
- 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).
- Experience: 5+ years of IT/Business Analysis experience supporting software implementations in GxP/Pharmaceutical environments.
- Key Tools & Systems: Service Now (Incident/Change/Problem), Track Wise (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).
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