Quality Assurance Specialist, Batch Disposition

Role: Quality Assurance Specialist focusing on Batch Disposition to ensure timely, compliant release of clinical and commercial biopharmaceutical products. Responsibilities: leading batch record review and disposition activities, making quality-based release decisions for raw materials, intermediates, and finished products; partnering with Manufacturing and Quality teams to maintain GMP compliance; supporting investigations, deviations, CAPAs, Change Controls, and audits; reviewing and approving controlled documents; driving continuous improvement in quality systems and operational efficiency. Qualifications: Bachelor’s degree in Biology, Engineering, Microbiology, Chemistry, Biochemistry, or related; at least 5 years' GMP-regulated QA experience, with proven expertise in batch review, product release, and regulatory inspection support—preferably within cell culture, purification, or aseptic fill-finish processes. High-Value: GMP, biopharma (clinical and commercial), manufacturing support, deviation and CAPA management, FDA audit experience. WorkSetup: onsite in Durham, NC; two shift options (first or starting at 12:00 PM), Monday–Friday.