Quality Systems Leader, Plasma Center

Grifols, S.A; California; Vor Ort; USD 75.000 - 112.000; Vollzeit

Benefits dieser Stelle

Medical, Dental, Vision

PTO

Tuition reimbursement

401(k) match

Zusammenfassung

Grifols Biomat CA is seeking a Quality Systems Manager to lead the center's quality programs and regulatory compliance. You will oversee audits, CAPAs, and staff training to ensure donor safety and product quality.

Responsibilities include interpreting SOPs, coordinating with Center Managers, and driving continuous improvement in line with cGMP and CLIA guidelines. A BS degree and 2–5 years in regulated healthcare environments are required.

Qualifikationen

• Bachelor of Science degree or equivalent.
• Certified and proficient in quality and compliance.
• Pursuing ASQ Certified Quality Auditor.
• Pursuing Designated Trainer certification.

Aufgaben

• Ensure center compliance with quality standards and regulations.
• Collaborate with Center Managers on product quality and donor safety.
• Oversee audits and corrective/preventive actions, and related documentation.
• Lead root-cause analysis for deviations and customer complaints.
• Develop staff knowledge and training and manage personnel records.

Kenntnisse

Quality systems

Regulatory compliance

Root cause analysis

Documentation

Ausbildung

Bachelor of Science

Quality/compliance certification

ASQ Certified Quality Auditor (in progress)

Designated Trainer certification (in progress)

Jobbeschreibung

Grifols Biomat CA is seeking a Quality Systems Manager to lead the center's quality programs and regulatory compliance. You will oversee audits, CAPAs, and staff training to ensure donor safety and product quality.

Responsibilities include interpreting SOPs, coordinating with Center Managers, and driving continuous improvement in line with cGMP and CLIA guidelines. A BS degree and 2–5 years in regulated healthcare environments are required.