QA Specialist III

• Lead/participate in project team to streamline Clinical QA processes and SOPs by reviewing existing workflows and identifying areas for improvement.

• Perform SOPs periodic review, write/revise SOPs and design process flowcharts

• Responsible for ensuring CAPA/ audit observations responses are appropriately implemented and closed in a timely manner

• Coordinate inspection and audit support for Clinical QA during internal / regulatory inspections and audits

• Manage Clinical QA training requirements and curricula, OJT qualification programs, and New Employee Onboarding programs to drive improved employee qualification and training compliance

• Maintain systems for organizing, tracking, trending and reporting Deviation, CAPA, batch disposition and review metrics

• Review existing quality workflows and assist in identifying areas for improvement. Write, revise and may review standard operating procedures.

• Other responsibilities as assigned