Quality Specialist (Bilingual)

About the role

The Quality Specialist provides immediate support to the Assistant Manager of Quality, ensuring plasma center processes comply with CSL Operating Procedures and all applicable regulations. This bilingual position monitors compliance, coordinates training, and represents the center during audits.

Key responsibilities

• Perform final QA review and release for all shipments and associated documentation.
• Maintain and review personnel training records to ensure alignment with CSL SOPs, CLIA/COLA, and regulatory requirements.
• Manage the Learning Management System, ensuring data integrity, reporting, and analysis.
• Schedule, coordinate, and monitor delivery of all training activities, including new‑hire and annual retraining.
• Collaborate with center management to identify non‑conformities, conduct investigations, and develop corrective action plans.
• Report compliance status data to operational quality management and support continuous‑improvement initiatives.

Required profile

• Bilingual proficiency (English and a second language).
• Strong understanding of regulatory requirements for plasma processing (e.g., CLIA, COLA).
• Experience reviewing SOPs and conducting internal/external audits.
• Ability to investigate deficiencies and document corrective actions.

Required skills

• Familiarity with Learning Management Systems.
• Knowledge of CSL operating procedures and quality management systems.