Quality Assurance Manager — Plasma Center

NCBioImpact; Hendersonville (NC); On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

Health & Wellness

Financial Security

Work-Life Balance

Career Growth

Extra Perks

Job summary

Kedrion Biopharma Inc. is seeking a Quality Assurance Manager to lead quality initiatives across plasma collection operations in a regulated environment.

You will manage audits, documentation, and staff training, and you may stop production or shipments to protect donor safety and product quality. You will collaborate with the Center Manager to ensure compliance with FDA and EU GMP standards, drive continuous improvement, and maintain audit readiness.

Qualifications

• Bachelor’s degree or equivalent experience in healthcare or life sciences.
• 3-5 years in plasma industry or biomedical field.
• 1+ year in a regulated industry; cGMP experience preferred.

Responsibilities

• Oversee all quality operations at the plasma center, ensuring compliance with FDA, EU GMP, cGMP, and internal standards.
• Review plasma collection records and activities to verify 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.
• Ensure proper documentation and record-keeping for all quality-related activities.
• 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.

Skills

Strong organizational, analytical and

Team leadership

Travel willingness

Education

Bachelor’s degree in healthcare, life sciences

Tools

Microsoft Office

Job description

Kedrion Biopharma Inc. is seeking a Quality Assurance Manager to lead quality initiatives across plasma collection operations in a regulated environment.

You will manage audits, documentation, and staff training, and you may stop production or shipments to protect donor safety and product quality. You will collaborate with the Center Manager to ensure compliance with FDA and EU GMP standards, drive continuous improvement, and maintain audit readiness.