Quality Assurance Manager

Job description

Essential Job Responsibilities and Duties: - Facilitating and evaluating center and equipment readiness - Responsible for all quality personnel functions including hiring, assignment and direction of work, development and training, disciplinary actions and termination, and the maintenance of all quality personnel records - Oversee daily actions that facilitate product collection (sample collection and submission; testing results, staging) - Assist the Quality Assurance Unit (QAU) ensuring donor center records are complete and accurate - Ensure shipments (sample, product, waste, etc.) are managed and labeled accurately - The interpretation and application of SOPs; and, ensuring SOP revisions are implemented correctly, efficiently and effectively - The receipt, approval and release of donor center supplies. - Assist Center Management and Training Coordinator to ensure training is conducted and documented as directed, review and prepare for inspections/audits, and to develop CAPA, and other quality duties as assigned - Oversee and manage the center’s Deviation Management System to ensure adequate investigations are completed, accurate root cause(s) identified, and CAPA process is iden...