Quality Assurance Specialist, Batch Disposition

Novartis•Durham, NC

10d•Onsite

About The Position

Every batch released has the potential to impact patients' lives, and that's where you come in. As a Quality Assurance Specialist, Batch Disposition, you will play a critical role in ensuring the quality, compliance, and timely release of clinical and commercial products. Working at the intersection of Quality, Manufacturing, and Operations, you will lead batch review and disposition activities, provide GMP oversight, and help maintain the highest standards of quality and regulatory compliance. This is an opportunity to make meaningful contributions to product release decisions while driving continuous improvement in a fast-paced and collaborative environment.

Requirements

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.
Strong attention to detail, sound quality judgment, and the ability to manage competing priorities in a fast-paced environment.

Nice To Haves

Collaboration
Communication
Data Integrity
Good Manufacturing Practices (GMP)
Internal Quality Auditing
Managing Ambiguity
Operational Excellence
Quality Assurance (QA)
Quality Compliance
Quality Control (QC)
Quality Management Systems (QMS)
Regulatory Compliance
Standard Operating Procedure (SOP)
Statistical Process Control (SPC)

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.