Quality Systems Manager, Plasma Donation Center

Responsibilities Evaluates processes, develops action plans, and coordinates the strategic implementation of quality system processes and corrective actions at the plasma donor center. Maintains oversight of the center’s quality management system and ensures continuous quality improvement. Directs and monitors processes and ensures center compliance with all applicable state, federal, and company-designated regulations. Implements Standard Operating Procedures (SOPs) for quality control and overall regulatory compliance. Maintains oversight of center training program by ensuring compliance to program requirements promoting staff competency in their assigned job duties. Collaborates with Center Manager to ensure the donor center operates in a manner which assures product quality, donor suitability and donor safety are maintained. Responsible for the personnel functions of the Quality Systems Associate; including direction, assignment of work, hiring, development and training, disciplinary actions, termination, maintenance of personnel records, work schedule and delegation/follow-up of tasks. Responsible for oversight of all aspects of internal and external audits. Requirements Bachelor of Science degree or equivalent. Typically requires 2 years of related experience in a medical and/or cGMP regulated environment. Experience with plasma or whole blood preferred. Ability to understand and assess FDA regulations. Strong integrity and commitment to quality and compliance. Full command of mathematics. Legible handwriting. High level of proficiency with computers. Proven ability to maintain a high level of quality and compliance and to become a valuable member of the center leadership team. Ability to work with minimal supervision. #J-18808-Ljbffr Jobtailor