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.)