QA Area Specialist I - SDF (2nd shift)

Role: QA Specialist within Novo Nordisk's Durham manufacturing site, focusing on ensuring compliance of Batch Production Records and quality processes with regulations and SOPs. Responsibilities: review and approve documentation, support investigations and root cause analyses using LEAN tools, participate in process verifications, evaluate data for management reviews, and support audit processes. Requirements: Associate’s degree in life sciences or related field; minimum 2 years QA or pharmaceutical quality experience; knowledge of pharmaceutical regulations and quality systems preferred; strong communication and computer skills. HighValue: pharmaceutical manufacturing, quality assurance, regulatory compliance, GMP, batch record review, investigations, audits, and process verification in a biologics or small molecule setting. WorkSetup: on-site at Durham facility; physical capacity to work in loud environments and handle materials up to 33 pounds.