Quality Assurance Lead - Regulatory & Training

CSL; Lumbrook (DE); Sur place; USD 65 000 - 90 000; Plein temps

Résumé du poste

CSL is seeking a quality operations specialist to support the Assistant Manager of Quality in monitoring plasma center processes for compliance with CSL SOPs and regulatory requirements. You will manage training, participate in audits, maintain training records, and drive corrective actions with center management to ensure ongoing quality, safety and regulatory adherence across daily operations.

This role requires attention to detail, strong organizational skills, and the ability to coordinate

Qualifications

• High school diploma or equivalent required; associate or bachelor’s degree preferred.

Responsabilités

• Perform final QA review and release for shipments and documents to meet customer specifications.
• Ensure center QA reviews for thoroughness and timeliness; document regulatory deficiencies and determine corrective actions.
• Maintain and review Plasma center personnel training documents to comply with CSL procedures and regulatory requirements (CLIA/COLA, etc.).
• Manage Learning Management System data integrity, reporting, and analysis.
• Coordinate and monitor training delivery (new hire, annual, retraining) to meet regulatory requirements.

Connaissances

Leadership

Customer Service

Critical Thinking

Organization

Quality Systems

Formation

High school diploma or equivalent

Associate or Bachelor’s degree preferred

Description du poste

CSL is seeking a quality operations specialist to support the Assistant Manager of Quality in monitoring plasma center processes for compliance with CSL SOPs and regulatory requirements. You will manage training, participate in audits, maintain training records, and drive corrective actions with center management to ensure ongoing quality, safety and regulatory adherence across daily operations.

This role requires attention to detail, strong organizational skills, and the ability to coordinate