Production Document Control Area Specialist I - SDF (BULK)

Role: Support batch documentation review and troubleshooting in pharmaceutical manufacturing at Novo Nordisk's Durham facility, focusing on oral treatments for type 2 diabetes. Responsibilities: conduct real-time and post-production batch reviews, ensure compliance with cGMPs, ISO, and internal SOPs, support audits, and manage documentation processes for batch release; contribute to continuous improvement initiatives. Requirements: Associate’s Degree in Life Sciences, Pharma, or related field plus 1 year GMP experience and 2 years in electronic documentation; alternatively, a High School Diploma with 5 years GMP experience. Skills: strong attention to detail, proficiency with IT tools (e.g., Excel, SAP, Adobe), knowledge of regulatory standards (FDA), problem-solving, and teamwork. Preferred: Bachelor’s Degree in related fields and experience fostering cross-organizational knowledge sharing. High-Value: pharmaceutical manufacturing, documentation compliance, GMP regulations, cGMP, ISO standards, oral dosage form production, audit support, regulatory compliance. Work setup: on-site in Durham with up to 10% travel.