Senior Associate II, Quality Assurance at Resilience in Durham, NC

PURPOSE AND SCOPE OF POSITION:The QA Shop Floor Senior Specialist is responsible for quality activities supporting Manufacturing Operations in accordance with the company policies, standards, procedures and Global cGMP. Functional responsibilities include ensuring manufacturing compliance with applicable procedures, providing real time review of manufacturing records and logbooks, and working with Manufacturing Operations to resolve issues. Must be action-oriented and skilled in decision-making, building relationships, problem solving, conflict management, planning and organizing, resource allocation, coaching others, and analytical thinking. Understands continuous improvement and improves efficiency and productivity within the group or project. Builds relationships internally within and with cross functional teams. Contributes to goals within the work group. Must have sound knowledge and experience in FDA regulated cGMP Quality Manufacturing operations and processes. Directs quality initiatives that accomplish continuous improvement and enhance site quality system efficiencies. Routinely recognizes and resolves Quality issues; Informs management of proposed solutions. Seeks management guidance on complex issues. Able to recognize conflict and notify management with proposed recommendations for resolution Education andExperience:Bachelor's Degree required Minimum 5 years relevant work experience, with at least three years in a Quality Assurance Shop Floor Manufacturing role. Experience working in a GMP Aseptic manufacturing environment required. Equivalent combination of education and experience acceptable. DUTIES ANDResponsibilities:Build and maintain relationships with Manufacturing Operations, Quality Control, Manufacturing Science & Technology and other departments to effectively accomplish responsibilities, make improvements and resolve issues. Perform QA shop floor activities, focused on Manufacturing Operations Ensure compliance with applicable procedures and production requirements. Perform real time review of manufacturing records. Must have strong authorship and ability to critically review investigations, interpret results and generate technical conclusions consistent with Quality risk management principles. Must be skilled in planning and organizing, decision-making, and building relationships. Knowledge of quality processes, including material disposition, material storage and handling requirements, change control, product complaints, deviations, investigations, and CAPA management. Must be available for weekend and off-shift hours Must be able to work in the cleanroom environment for 6 hour time periodsSalary Range:$80K -- $100KMinimum QualificationQuality AssuranceEstimated Salary: $20 to $28 per hour based on qualifications.