Quality Assurance Area Specialist II - API

Role: QA Reviewer in pharmaceutical manufacturing, focusing on API batch review, deviation and change control approval, and process oversight. Responsibilities: review API batch documentation across systems, ensure compliance with cGMP and ISO standards, provide guidance on quality activities, participate in root-cause analysis and process confirmations, and support quality improvements. Requirements: Bachelor's in Life Sciences, Engineering, or related field; minimum 3 years' QA or related experience in pharma/medical device industry; strong understanding of cGMP manufacturing, batch review, and quality management systems; proficient in MS Office; excellent communication skills. High-Value: pharmaceutical API manufacturing, QA batch review, deviation/variance approval, cGMP compliance, quality oversight, process confirmation. WorkSetup: onsite at Novo Nordisk's API facility in Clayton, NC; physical ability to handle equipment and work in a manufacturing environment; may involve working at heights and around hazardous materials.