Manufacturing Quality Assurance Specialist

Role: Manufacturing Quality Assurance Specialist supporting GMP-biopharma manufacturing in Durham, NC. Objectives include ensuring production compliance, quality oversight, and continuous improvement from shop floor to product release. Responsibilities: perform real-time quality reviews, approve batch records, support manufacturing operations (media, cell expansion, aseptic filling), lead deviation investigations, review alarms and data integrity, coordinate audits/inspections, and analyze quality metrics. Qualifications: BS in microbiology, chemistry, or biochemistry; 5+ years in regulated GMP manufacturing; strong knowledge of CFR, FDA, EU regulations; experience supporting regulatory audits; expertise in quality procedures and investigations; excellent communication skills. Preferred: experience with viral gene therapies or orphan diseases, leading internal quality audits. HighValue: GMP manufacturing, biopharma (potentially cell/gene therapy), regulatory compliance, audit readiness, batch record review, deviation management. WorkSetup: onsite in Durham, first shift (7:00 am - 3:30 pm). No travel specified.