Senior System Analyst for Quality Systems
Alcor Solutions Inc. - Edison, NJ

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Senior Systems Analyst for Global Quality Systems. This consulting assignment requires a BS/MS in Computer Science (or equivalent) and 3+ years (7+ years for Sr.) experience in IT within an FDA-regulated industry.

Day in the Life:

  • Systems analysis, design, configuration, and programming to meet requirements.
  • Collaborative analysis and documentation/understanding of business system requirements.
  • Manage and analyze changes to applications according to business needs.
  • Interface directly with various IT functional areas as it pertains to the support of applications.
  • Creating and executing SDLC documents.
  • Make recommendations for process improvements.
  • Anticipate issues and recommend solutions.
  • Train other personnel as needed.

What You Bring to the Team:

  • Experience with global systems/deployments.
  • Experience with complex application configurations.
  • Experience in a regulated/validated environment
  • Ability to effectively interface with clients and the technical team.
  • System Administration experience.
  • Programming/Development/Configuration experience.
  • Support of multiple client areas.
  • Ability to work and contribute in a team environment.
  • Ability to perform tasks with minimal supervision.
  • Preferred: Previous experience in configuration of commercial quality management systems e.g. SmartSolve, QAAD, Trackwise, Metric Stream , AssureX, EtQ Reliance
  • Preferred: Python scripting experience (preferred).
  • Preferred: Applied Knowledge of 21 CFR Part 11 (Required), GxP regulations and GAMP
  • Preferred: Knowledge of QA business process (Complaints Handling, CAPA, Deviations/Investigations, Change Control, Audit, Vendor Management, etc.)