Quality Systems Manager ensuring compliance and quality improvement at plasma donor center. Leading audits and training to maintain the highest standards in healthcare.
Responsibilities
Evaluates processes, develops action plans, and coordinates the strategic implementation of quality system processes
Maintains oversight of the center’s quality management system
Directs and monitors processes and ensures center compliance with all applicable state, federal, and company-designated regulations
Maintains oversight of center training program by ensuring compliance to program requirements
Collaborates with Center Manager to ensure the donor center operates in a manner which assures product quality
Responsible for the personnel functions of the Quality Systems Associate
Responsible for oversight of all aspects of internal and external audits
Continuously assesses, promotes, and improves the effectiveness of quality and training systems in the donor center
Documents, investigates, and performs root-cause analysis for deviations and customer complaints
Investigates identified trends and performs follow-up on corrective and preventative actions
Oversees product and biohazard waste shipments
Performs a review of the documentation of unsuitable test results
Performs a review of donor adverse event reports
Ensures that job and center annual training is completed
Performs employee training observations to ensure staff competency
Ensures that all supplies and materials ordered meet quality requirements
Determines donor suitability activities and manages donor deferrals as appropriate
Prepares quality analysis reports to track issues and set goals
Ensures that Clinical Laboratory Improvement Amendments (CLIA) proficiency test surveys, complaint investigations, and training have been properly documented
Holds monthly Quality Meeting to communicate status updates and manage action outcomes
Requirements
Bachelor of Science degree or equivalent
Typically requires 2 years of related experience in a medical and/or cGMP regulated environment
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