Demo

QC IT Application Analyst

Katalyst Healthcares and Life Sciences
Lexington, MA Full Time
POSTED ON 2/17/2025
AVAILABLE BEFORE 5/15/2025

Responsibilities :

  • Project upgrades from win 7- win 10.
  • Provide oversight of vendor-provided solutions.
  • Handle ad-hoc technical requests from both internal and external partners in accordance with projects that are assigned.
  • Experience with performing design testing of application to help author SDLC documents, including SDCS, URS, FRA, Admin Sop, IQ, IOQ, ATR, Application Data Flow diagrams, etc.
  • Service now, Veeva, Trackwise, Active Directory, firewall rules, My Access, NTFS permissions.
  • Applications impacted by upgrades, Ideal candidate should have previous experience implementing, and or upgrading.
  • Other application experience can be considered.
  • Vaya Raman, 7500 Fast PCR, Hiac Particle Counters, Maldi-tof, Vi-Cell Cell counter, Antaris II, Waters Andrew Alliance.

Requirements :

  • More than 10 years relevant IT / business experience, analysis, and documentation of business and technical requirements (required).
  • Bachelor's degree or equivalent in information technology, computer science, engineering, or business administration.
  • Experience in the Pharmaceuticals or Life Sciences industry.
  • Knowledge of Lean operational techniques.
  • IT Experience deploying and supporting Quality and Manufacturing Systems including Analytical Instruments, and various Laboratory desktop applications used in GxP environment.
  • Familiarity with Automation systems such as SCADAs, PLCs, DCS, Client, Historians.
  • Experience with Computerized Systems Validation (CSV), 21 CFR Part 11 regulations, and Data Integrity compliance.
  • Experience working with ITIL processes in ServiceNow such as Incident Management, Change Management, Problem Management, Asset and Configuration Management (CMDB).
  • Familiarity with following tools and processes - TrackWise - CAPA, Deviation, Change Control Veeva - Document Workflows.
  • Familiarity with Operational Excellence and / or Continuous Improvement processes.
  • Knowledge and familiarity of following Tools and technologies MS Office 365, MS Visio, MS Project Citrix, Windows Desktop, Windows Server, SQL Databases, LDAP, Group Policy, TCP / IP Networks, Server Virtualization, RDP, Backup and Restore Architectures - 2 Tier, 3 Tier, On-premises, Cloud.
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