Reagent Scientist

Key Responsibilities: Provide comprehensive Quality Assurance oversight and support for Reagent manufacturing processes – e.g., SOP approvals, equipment record approvals, non conformances, out of specification events, etc. Ensure rigorous adherence to design change procedures, corporate policies, and global regulations (e.g., FDA QSR, ISO). Proactively offer guidance and make informed decisions to prevent deviations and non‑conformances. Collaborate effectively with cross‑functional teams to swiftly identify, contain, and disposition non‑conforming product. Interact proficiently with development, technical operations, and manufacturing personnel to sustain high quality standards, minimize rework and waste, and optimize product satisfaction. Establish and drive daily management actions for quality processes, ensuring alignment with broader departmental and organizational initiatives. Evaluate quality system performance metrics and lead continuous improvement events to enhance process efficiency and overall effectiveness. Qualifications: Bachelor’s degree in a science or engineering discipline with a minimum of 5 years of relevant experience, OR Master’s degree in a science or engineering discipline with a minimum of 3 years of relevant experience, OR Doctoral degree in a relevant field. Proven experience performing Quality Assurance functions within a regulated industry. #J-18808-Ljbffr Sunrise Systems, Inc.