JOB SUMMARY

The Specialist I, QA Compliance (Plasma Operations) is responsible for providing Quality Assurance oversight of plasma-related activities in support of hyperimmune pharmaceutical manufacturing. This role ensures that plasma sourcing, handling, processing, and associated quality systems comply with current Good Manufacturing Practices (cGMP), regulatory requirements, and internal quality standards.

The Specialist I also plays a key role in maintaining inspection readiness, supporting regulatory and customer audits, and ensuring the effective execution of quality systems. This position partners cross-functionally to support product quality, patient safety, and continuous improvement.

ESSENTIAL FUNCTIONS

Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.

Quality Systems: