Job Information
Nucleus RadioPharma Quality Control Chemist in Rochester, Minnesota
Supports the development and leads the execution of QC methods for radioactive drug products in a GxP environment, including radio-HPLC, TLC, GC, gamma spectroscopy, endotoxins, pH, etc. Supports the execution of laboratory equipment qualification, ensuring all instruments are properly validated and calibrated. Assists in supervision of the QC Chemistry team which includes mentoring, assigning tasks, setting performance goals, training, coaching, and offering performance and development management. Provides support and assistance for laboratory personnel in daily activities to fulfill client and GMP requirements. Performs trend analysis of QC analytical results. Assists in Out of Specification investigations. Responsible for training QC Technicians on cGMP guidelines 21 CFR 210, 211, 212,as applicable. Responsible for training QC Technicians in analytical and QC testing methods. Serves as Subject Matter Expert for Quality Control testing on site. Collaborate with other groups within the facility to understand goals and communicate changes throughout the organization. Provide input for strategic planning for new product lines. Work closely with QC Manager and scientific staff to evaluate technical feasibility of new products. Supports in maintaining QC budget and responsible for communicating QC laboratory staffing and budget needs. Assists in Writing, maintaining, and updating necessary Standard Operating Procedures (SOPs), Validation Protocols and Validation Report. Performs other duties as assigned.
