Quality Assurance Supervisor

Quality Assurance Supervisor - Overnight Shift (Sun-Wednesday nights)About UsEvergreen Theragnostics, Inc. is a radiopharmaceutical company headquartered in Springfield, NJ. We operate in a brand-new state-of-the-art facility, developing our own radiopharmaceutical products and providing contract development and manufacturing services for other radiopharmaceutical companies. We also operate our own cutting edge cancer research laboratories. Evergreen is a small team, where all team members support each other in a variety of activities. We are looking for team members who are motivated to take on new challenges and excited to help build the company.Job ResponsibilitiesOversee all day-to-day QA operations and related activities for the overnight shift.Manage a team of Quality Assurance professionals supporting routine batch release activities.Plan, execute, oversee inspection and testing of incoming and outgoing products to confirm quality conformance to specifications and quality deliverables.Responsible for disposition of incoming production materials and release activities for site manufactured drug products.Responsible for managing Quality Assurance Key Performance Indicators (KPIs) such as document review cycle times, and Quality Event cycle times.Author documents and standard operating procedures, review and approve investigations, interpret results and generate technical conclusions consistent with Quality risk management principles.Identify potential risks before they become a problem, focusing on root cause analysis and driving preventive action.Perform internal and external quality audits and compile detailed reports of findings.Develop and provide training and support to quality and production teams on systems, policies, procedures, and core processes.Analyze and investigate product complaints or reported quality issues to ensure closure in accordance with company guidelines and external regulatory requirements.Develop or update company complaint and inspection procedures to ensure capture and investigation, as well as proper documentation of teract with CDMO clients to advise on protocol driven activities related to process development, update and validation related to QA requirements.Support daily QA activities and other work-related duties as assigned.QualificationsSkills:Bachelor's Degree in a scientific field.5-8 years of experience in the pharmaceutical industry required. Previous supervisormanagement experience preferred.Batch dispositionbatch release experience preferred.Understanding of FDA, and other applicable regulatory requirements for finished pharmaceuticals.Strong technical writing and oral communication abilities · Experience working with electronic quality management and laboratory information management systems.Ability to work with computers and software applications, such as Microsoft OfficeAbility to work in a small team setting.

Created: 2025-03-01