Quality Assurance: Batch Disposition Lead (Onsite Durham)

Novartis Group Companies; Durham (NC); On-site; USD 90,000 - 166,000; Full time

Job summary

Novartis Group Companies in Durham, NC seeks a Quality Assurance Specialist, Batch Disposition, to lead batch review, ensure GMP compliance, and drive timely product releases for clinical and commercial products. You will collaborate with Manufacturing and Quality to uphold regulatory standards and support audits.

The role requires a Bachelor's in science and at least 5 years in batch disposition or QA within GMP environments; you will manage deviations, CAPAs, change controls, and document

Qualifications

• Bachelor's degree in a scientific discipline.
• 5+ years in Batch Disposition or QA within GMP environment.
• Experience reviewing batch records and supporting product release.
• Strong GMP regulations knowledge and quality systems.

Responsibilities

• Lead batch record review and disposition to support timely release.
• Make quality-based disposition decisions for materials and products.
• Ensure GMP compliance across production operations.
• Support regulatory releases for clinical and commercial products.
• Issue and manage batch records and documentation.
• Review, author, and approve SOPs and specifications.
• Drive investigations, deviations, CAPAs and Change Controls.
• Support internal audits and FDA inspections readiness.
• Monitor quality metrics and contribute to Quality Management reports.
• Identify continuous improvement opportunities for Quality Systems.

Skills

Batch Disposition

GMP Knowledge

Documentation Review

Deviations & CAPA

Regulatory Inspections

Quality Systems

Cross-functional Collaboration

Attention to Detail

Education

Bachelor's degree in Biology, Engineering, Microbiology, Chemistry, Biochemistry

Job description

Novartis Group Companies in Durham, NC seeks a Quality Assurance Specialist, Batch Disposition, to lead batch review, ensure GMP compliance, and drive timely product releases for clinical and commercial products. You will collaborate with Manufacturing and Quality to uphold regulatory standards and support audits.

The role requires a Bachelor's in science and at least 5 years in batch disposition or QA within GMP environments; you will manage deviations, CAPAs, change controls, and document