QA Batch Disposition Lead – Onsite Durham

Novartis; North Carolina; On-site; USD 90,000 - 166,000; Full time

Job summary

Novartis in Durham, NC is seeking a Quality Assurance Specialist, Batch Disposition to lead batch review and disposition activities ensuring timely product release. This onsite role sits at the nexus of Quality, Manufacturing, and Operations, collaborating across teams to uphold GMP compliance and regulatory readiness.

You will drive investigations, CAPAs, deviations, and change controls, review controlled documents, and support audits and site performance initiatives in a fast-paced

Qualifications

• Bachelor’s degree in Biology, Engineering, Microbiology, Chemistry, Biochemistry, or a related scientific discipline.
• Minimum 5 years of experience in Batch Disposition and/or Quality Assurance within a GMP-regulated environment.
• Proven experience performing batch record review and supporting product release activities.
• Strong knowledge of GMP regulations and quality systems within the biopharmaceutical industry.
• Experience supporting manufacturing operations, including cell culture, purification, or aseptic fill-finish processes.
• Demonstrated experience managing deviations, CAPAs, and Change Controls.
• Experience supporting regulatory inspections and health authority audits, including FDA inspections.

Responsibilities

• Lead batch record review and batch disposition activities to support timely product release.
• Make quality-based disposition decisions for raw materials, consumables, intermediates, and finished product.
• Partner with Manufacturing and Quality teams to ensure GMP compliance throughout production operations.
• Support release of clinical and commercial products in accordance with regulatory requirements.
• Issue and manage batch records and associated manufacturing documentation.
• Review, author, and approve SOPs, work instructions, specifications, and other controlled documents.
• Drive investigations, deviations, CAPAs, and Change Controls impacting product quality and release.
• Support internal audits, regulatory inspections, and ongoing FDA inspection readiness activities.
• Monitor quality metrics and contribute to Quality Management Review reporting and site performance initiatives.
• Identify and implement continuous improvement opportunities that strengthen Quality Systems and operational effectiveness.

Skills

Batch Disposition

GMP Compliance

Quality Assurance

Documentation Management

Deviation & CAPA

Regulatory Inspections

Education

Bachelor’s degree in Biology/Engineering/Microbiology/ Chemistry

Job description

Novartis in Durham, NC is seeking a Quality Assurance Specialist, Batch Disposition to lead batch review and disposition activities ensuring timely product release. This onsite role sits at the nexus of Quality, Manufacturing, and Operations, collaborating across teams to uphold GMP compliance and regulatory readiness.

You will drive investigations, CAPAs, deviations, and change controls, review controlled documents, and support audits and site performance initiatives in a fast-paced