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 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.
- Collaborates with Center Manager to ensure the donor center maintains product quality, donor suitability and donor safety.
- Responsible for oversight of all aspects of internal and external audits including audit preparation and response.
Requirements
- Bachelor of Science degree or equivalent.
- 2 years of related experience in a medical and/or cGMP regulated environment.
- Experience with plasma or whole blood preferred.
- Strong integrity and commitment to quality and compliance.
- Ability to understand and assess FDA regulations.
- Proficient in root cause analysis and corrective/preventative actions.
Benefits
- medical
- PTO
- up to 5% 401K match
- tuition reimbursement