Quality Assurance Manager – Plasma Center Operations

Kedrion; Hendersonville (NC); Sur place; USD 90 000 - 130 000; Plein temps

Avantages offerts par ce poste

Health coverage

Life insurance & retirement

Paid time off

Career development

Employee discounts

Résumé du poste

Kedrion Biopharma Inc. is seeking a Quality Assurance Manager to own compliance and operational excellence for plasma collection operations in a regulated environment.

You will lead quality initiatives, manage audits, and empower your team to uphold the integrity of life-saving plasma products. You’ll collaborate with the Center Manager, oversee documentation, training, product release, and regulatory readiness.

Qualifications

• Bachelor’s degree in healthcare, life sciences, or a related field.
• 3–5 years in plasma or biomedical field preferred.
• Minimum 1 year in a regulated industry; cGMP experience strongly preferred.
• Strong understanding of FDA, EU, and industry regulations.
• Excellent organizational, analytical, and documentation skills.
• Willingness to travel to other Kedrion locations as needed.

Responsabilités

• Oversee quality operations at the plasma center ensuring FDA/EU GMP compliance.
• Review plasma records for accuracy and adherence to SOPs.
• Investigate deviations and implement corrective actions to maintain compliance.
• Conduct audits and evaluations of procedures, equipment, and documentation.
• Monitor and report test results, quality control records, and preventive maintenance logs.
• Evaluate staff competency through direct observation, written assessments, and proficiency testing.
• Oversee plasma release and shipment verification, ensuring all specifications are met.
• Lead CLIA proficiency testing, complaint investigations, and certification tracking.
• Analyze quality data and trends to identify opportunities for improvement.
• Maintain readiness for internal and external audits and inspections.
• Collaborate with leadership to promote a culture of continuous improvement and regulatory excellence.

Connaissances

Leadership

Regulatory knowledge

Documentation

Analytical skills

Communication

Travel willingness

Formation

Bachelor’s degree in healthcare, life sciences, or related field

Outils

Microsoft Office

Description du poste

Kedrion Biopharma Inc. is seeking a Quality Assurance Manager to own compliance and operational excellence for plasma collection operations in a regulated environment.

You will lead quality initiatives, manage audits, and empower your team to uphold the integrity of life-saving plasma products. You’ll collaborate with the Center Manager, oversee documentation, training, product release, and regulatory readiness.