Specialist II Product Quality Assurance

Role: Support quality oversight of manufacturing and laboratory operations at Beam's cell and gene therapy facility in RTP, North Carolina, focusing on clinical-phase production with potential transition to commercial manufacturing. Responsibilities: oversee routine manufacturing, batch record review, deviation and CAPA management, QC testing, product disposition, calibration/maintenance approval, and support validation and tech transfer activities. Ensure GMP compliance, contribute to quality systems improvements, and participate in regulatory inspections. Requirements: Bachelor's or advanced degree in a scientific discipline with 3-4 years in pharma/biotech quality or manufacturing, knowledge of aseptic processing or cell/gene therapy preferred. Skills: strong communication, attention to detail, team collaboration, problem-solving, and working in cleanroom environments. HighValue: cell/gene therapy modalities, clinical phase manufacturing, GMP compliance, quality oversight of manufacturing/testing, regulatory support, on-site presence, flexible schedule. WorkSetup: onsite daily in RTP, North Carolina; may include support outside normal hours.