Quality Systems Manager - Grifols : Job Details

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Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce, and market innovative medicines, solutions, and services in more than 110 countries and regions.

• Conducts quality inspection and control to ensure center compliance with quality standards and regulations.
• Collaborates with Center Managers to ensure product quality, donor suitability, and donor safety.
• Directs and monitors processes, ensuring compliance with all applicable regulations.
• Ensures SOPs are properly interpreted, implemented, and followed by staff.
• Implements and interprets processes, regulations, and SOPs for quality control and compliance, making decisions as needed.
• Oversees audits, including documentation, review, and response preparation, and implements corrective actions.
• Assesses and improves quality systems through trend recognition, failure investigation, and employee review.
• Manages personnel functions of the Quality Associates, including hiring, training, and disciplinary actions.
• Oversees product and biohazard waste shipments, ensuring regulatory compliance and proper documentation.
• Reviews documentation of test results and dispositions, investigates deviations and complaints, and performs root cause analysis.
• Tracks incidents and trends, reports critical issues, and maintains accuracy of donor files.
• Maintains equipment calibration and documentation, and ensures compliance with CLIA and GMP standards.
• Prepares quality reports, manages donor suitability activities, and builds rapport with donors to ensure satisfaction.

Bachelor of Science or equivalent; certified in quality and compliance; working towards ASQ certification as a Quality Auditor; certification as a Designated Trainer in quality.

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Grifols is an equal opportunity employer. Location: Hollywood, FL. Seniority level: Mid-Senior level. Employment type: Full-time. Industry: Pharmaceutical and Medical Equipment Manufacturing.