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).
Numbers & Facts
Location
Lexington, MA
Skills
Analysis Skillsunmatched
Biotech and Pharmaceuticalunmatched
Business Administrationunmatched
Business Analysisunmatched
Code of Federal Regulationsunmatched
Computer Systemsunmatched
Computer Workstationsunmatched
Corrective and Preventative Action (CAPA) Systemsunmatched
Data Qualityunmatched
Data Recoveryunmatched
Desktop PCunmatched
Documentationunmatched
GMP (Good Manufacturing Practices)unmatched
GxPunmatched
Information Technology & Information Systemsunmatched
Laboratory Equipmentunmatched
Laboratory Systemsunmatched
Microsoft Active Directoryunmatched
Microsoft Windows 7unmatched
NTFSunmatched
Operational Supportunmatched
Polymerase Chain Reaction (PCR)unmatched
Quality Controlunmatched
ServiceNowunmatched
Software Administrationunmatched
Software Development Lifecycle (SDLC)unmatched
Software Patchesunmatched
Standard Operating Procedures (SOP)unmatched
System Validationunmatched
Systems Administration/Managementunmatched
Technical Supportunmatched
Test Plan/Scheduleunmatched
Testingunmatched
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