US-Illinois-Northbrook: Senior QA Associate
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Senior QA Associate
1. Executes tasks associated with Computerized System Validation (CSV) as an individual contributor which includes collecting and classifying information appropriately. Updates related User and Functional requirements in a timely manner. Generates status reports as required and maintains the requirements.
2. Subject Matter Expert (SME) in one or more of the Computerized System Validation: Good Documentation Practices Training, Test Scripts, Change Control, System Development Lifecycle (SDLC) and SAP.
3. Utilizes technical skills and tools effectively to identify issues, evaluate risk and facilitate appropriate solutions to management.
4. Coordinates the collection and tabulation of metrics related to the CSV as directed by supervisor.
5. Assures SDLC/CS compliance with corporate policies, SOPs and regulatory agency standards. Identifies issues and initiates corrective action as required.
6. Assists in the coordination of execution of protocols and training as necessary.
7. Collaborates with departmental and cross-functional teams to address SDLC/CSV compliance issues and complete projects as assigned.
8. Participates in the development of a comprehensive risk management process and risk based approaches related to computerized system validation activities.
9. Authors, revises, and performs maintenance and administration of departmental controlled documents (i.e., policies, SOPs, WPDs, Forms, etc) as necessary.
10. Project management of assigned projects.
Minimum BA/BS with 3-4+ years of industry experience with a minimum of one year of Validation/IT experience
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Team SQAFYI - Software QA Resource FYI