About this role
Role Overview
- 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
Benefits
- medical
- PTO
- up to 5% 401K match
- tuition reimbursement