Senior Quality Assurance Specialist - 2nd shift!

Essential Duties and Responsibilities: Applies GMP/GLP in all areas of responsibility, as appropriate Applies the highest quality standard in all areas of responsibility Demonstrates and promotes the company vision Regular attendance and punctuality Demonstrates strong client service skills, teamwork, and collaboration Proactively plans and multitasks to maximize productivity Meets all quality and productivity metrics and demonstrates strong teamwork and collaboration Use opportunities to contribute to continuous quality and process improvement of QA department and of the laboratories Demonstrate understanding of QAU operations and functions Perform investigation writing and review including thorough root cause analysis and CAPA Perform internal audits and walk through inspections Review procedures, methods and protocols Release analytical reports Host client audits, appropriately respond to findings and recommendations Provide information/entries for monthly/quarterly quality reports to management Conducts all activities in a safe and efficient manner Communicates effectively with clients and staff members Take initiative to diagnose problems, solve simple problems, and present suggestions for solutions to complex problems Review client or agency documents and identify requirements outside our usual practices, communicate to technical operations, assist with implementing appropriate changes Keep abreast of regulatory or industry quality assurance (QA) requirements, consult with clients or regulatory authorities regarding any special QA requirements they may have, assist technical operations with application and interpretation of regulations Assist and/or prepare and present training programs as needed to satisfy regulatory requirements Serve as mentor to specialists to successfully complete assignments Identify and drive process improvements, both within the department and for laboratory operations; determine the most effective way to accomplish a goal or strategy; suggest improvements to maximize quality and productivity while remaining compliant. Demonstrate skill in using the computer to access information, perform job functions (e.g., spreadsheets, power point), and prepare documents