Onsite QA Lead: Batch Disposition & Product Release

Novartis; Durham (NC); On-site; USD 59,000 - 110,000; Full time

Job summary

Novartis in Durham, NC is seeking a Quality Assurance Specialist, Batch Disposition to lead batch review and disposition activities, ensuring GMP compliance and timely product release in collaboration with Manufacturing and Quality teams.

The role requires a bachelor’s in a scientific field and at least five years in GMP batch disposition or QA, with experience in deviations, CAPAs, change controls, and FDA inspections.

Qualifications

• Bachelor’s degree in a scientific discipline.
• Minimum 5 years in Batch Disposition and/or QA in a GMP environment.
• Experience reviewing batch records and supporting product release.
• Strong GMP/regulatory knowledge in biopharma.
• Experience with deviations, CAPAs and Change Controls.
• Experience supporting regulatory inspections including FDA.
• Attention to detail and ability to prioritize in a fast-paced environment.

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 review

GMP compliance

Quality systems

Regulatory inspections

Attention to detail

Education

Bachelor’s degree in Biology/Engineering/Chemistry

Job description

Novartis in Durham, NC is seeking a Quality Assurance Specialist, Batch Disposition to lead batch review and disposition activities, ensuring GMP compliance and timely product release in collaboration with Manufacturing and Quality teams.

The role requires a bachelor’s in a scientific field and at least five years in GMP batch disposition or QA, with experience in deviations, CAPAs, change controls, and FDA inspections.