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Quality Specialist
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Full-time
- Under general direction, monitors plasma center processes to ensure compliance with Standard Operating Procedures (SOPs) and applicable local, state and federal requirements
- Ensures compliance to quality processes, regulatory requirements, SOPs and necessary training for plasma center and business operations
- Coordinates training and facilitates processes to support timely reporting of biologic product deviations to Food & Drug Administration (FDA)
- Ensures training materials/documents are maintained and modified regularly; maintains the Learning Management System to ensure data integrity, report generation and data analysis
- Leads internal audits to monitor facility compliance with SOPs, cGMP, OHSA, FDA, and other regulations, as applicable
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