We are seeking a highly skilled and motivated Quality Assurance Specialist to join our rapidly growing and dynamic COUR Team. COUR is a clinical-stage biopharmaceutical company located in Skokie, Illinois with the goal of developing first-in-class innovative therapeutic products designed to reprogram the immune system to treat autoimmune disorders from pre-clinical development through FDA approval and commercialization.

The QA Specialist will be responsible for providing vital quality leadership to ensure the manufacturing process, quality systems and finished products comply with cGMPs and all applicable government, customer, and company expectations for quality and safety. Responsible for leading quality assurance programs including Annual Product Review, Batch Record Review, Deviation/OOS Investigation, Stability, and Validation, as well as working closely with and supporting Quality Control on lab investigations, method development and qualification, and Operations on facility management and manufacturing.