Senior Quality Assurance Area Specialist I (QA or IT & Automation)

Role: Quality Assurance specialist overseeing production validation and batch release at Novo Nordisk's API manufacturing facility. Responsibilities: ensure compliance with regulatory standards, review and approve batch documentation, deviations, change controls, and SOPs; support validation projects and quality issue resolution; participate in root-cause analysis, process confirmations, and quality oversight; act as an authorized person per Novo Nordisk Quality Manual. Requirements: Bachelor's in Life Sciences, Engineering, or related field; minimum 5 years in pharmaceutical manufacturing; strong knowledge of cGMP, validation, and quality management systems; experience with batch review, deviations, and change controls; excellent communication and computer skills. Preferred: experience in biotech/pharma production environments, process validation, and quality oversight. High-value: expertise in cGMP manufacturing, validation processes, regulatory compliance, and batch review activities within a biopharma API context. Collaboration: reports to QA Manager, supports cross-functional teams on quality-related activities. Work setup: on-site at Clayton, NC, with physical demands including moving equipment, standing for long shifts, and working in noise-sensitive environments.