Associate

• Perform quality assurance and training functions under the direct supervision of the Quality Systems Manager
• Complete weekly reviews of equipment QC and maintenance records
• Document, investigate, and perform root-cause analysis for deviations and customer complaints related to product quality and donor safety
• Inspect and release incoming supplies; investigate and report supplies that fail quality specifications
• Perform documentation reviews for unsuitable test results
• Ensure compliance with cGMP regulations, SOPs, and regulatory requirements
• Perform all product release activities
• Review lookback information and documentation
• Review waste shipment documentation
• Review unexpected plasmapheresis events and related electronic donor chart documentation
• Review donor chart exceptions affecting donor eligibility, donor safety, or product quality
• Review donor deferral notifications from competitor centers
• Review plasma processing documentation for proper freezing, storage, and handling
• Create, maintain, and audit training records and files
• Conduct employee training observations to verify competency before independent work
• Conduct required training for center notifications, corporate directives, SOP changes, and initial SOP implementations
• When the Quality Systems Manager is absent, review and approve deferred donor reinstatement activities and assist with internal donor center audits
• Review monthly trending reports and donor adverse event reports
• Conduct training addressing donor center corrective and preventive measures

Explore Quality Systems Associate at Grifols. Review requirements and application details.