Quality Assurance Specialist, Batch Disposition

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

Job Description Summary

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.

Job Description

Location:

• This position will be located in Durham, NC and will be an onsite role.
• Novartis is unable to offer relocation support for this role: please only apply if this location is accessible for you.

Shift:

• We currently have two openings one first-shift role and one second-shift role (starting at 12:00 PM). Both positions are scheduled Monday through Friday.

Key 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.

Essential 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.

Novartis Compensation and Benefit Summary:

The salary for this position is expected to range between $43.00 and $80.00 per hour

The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors.

Your compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards.

US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits. In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves.

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EEO Statement:

The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status.

Accessibility and reasonable accommodations

The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or to perform the essential functions of a position, please send an e-mail to [e-mail] or call [phone] and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

Salary Range

$89,600.00 - $166,400.00

Skills Desired

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)