Perform software validation to ensure it meets design and customer requirements; perform regression testing on various software products; write detailed test cases and Test Plans during the validation process.
Provide Quality Unit oversight and approval for all site qualification and validation activities, work orders, regulatory submissions, pharmacovigilence, and contract manufacturing operations. Act as change control reviewer and support management of the change control system.
Maintain responsibility for the implementation of quality assurance in support of vehicles, products, and services. Establish quality standards for life cycle, documentation, and testing. Specify functional and nonfunctional requirements.
Creates and manages quality systems documentation (checklists, procedures, deciding on training needs, revising documents); manages formulas for products by revising or creating plant floor formulas, assuring compliance.
This positions role and day-to-day duties are primarily centered around automated software testing, and to an extent business analysis, though other duties outside of what is outlined below may be required. A successful candidate will excel in the duties outlined below:
The Quality Analyst is responsible for overall quality assurance throughout the application development cycle for their functional area. Through the leadership provided by the Quality Assurance Manager, the Quality Analyst will partner with the development team for overall code quality.
Serve on a team of risk evaluation and assurance professionals, working to provide an independent Second Line of Defense approach to risk-based monitoring and evaluation by focusing on current, high impact compliance risks, developing assessments, and providing input over control effectiveness through formal reporting, as well as monitoring remediation activities.