Manufacturing Quality Assurance Specialist

Novartis; Durham (NC); On-site; USD 66,000 - 110,000; Full time

Job summary

Novartis in Durham, NC is seeking a Manufacturing Quality Assurance Specialist who will be a hands-on partner to production teams, ensuring every stage meets quality and GMP standards, from shop floor presence to final release, influencing patient safety while driving continuous improvement in a fast-paced environment.

You will review batch records, lead deviation investigations, support audits, and help implement quality system enhancements, with a first shift 7:00 am to 3:30 pm, onsite only.

Qualifications

• BS degree in a scientific field (microbiology, chemistry, biochemistry)
• Minimum 5 years in a regulated GMP manufacturing environment
• Strong knowledge of CFR, FDA, and EU regulatory requirements
• Experience supporting FDA/EU inspections and audits
• Experience reviewing and approving quality procedures and SOPs
• Ability to manage deviations, investigations, and CAPA to closure
• Strong data analysis to identify trends and compliant paths forward
• Excellent written and verbal communication across functions

Responsibilities

• Provide proactive quality oversight on the shop floor and real-time manufacturing support.
• Review and approve master and executed batch records for compliance.
• Partner with manufacturing to ensure GMP-compliant processes.
• Support media, buffer, cell expansion, upstream, downstream, and aseptic filling operations.
• Lead deviation investigations with root-cause analysis and remediation.
• Review alarms, data integrity, and electronic records for regulatory compliance.
• Support internal and external audits and inspections readiness.
• Provide quality expertise in batch record design, review, and improvements.
• Analyze quality metrics and communicate actionable insights to management.
• Lead or contribute to continuous improvement and quality system projects.

Skills

Quality oversight

GMP compliance

Data analysis

Regulatory inspections

Batch records review

Deviation investigations

CAPA closure

Cross-functional communication

Education

Bachelor of Science in microbiology/chemistry/biochemistry

Tools

Regulatory guidelines (CFR/FDA/EU)

Job description

Summary

Quality is not just a checkpoint here—it is the promise we make to patients. As a Manufacturing Quality Assurance Specialist at Novartis, you will be a hands‑on partner to manufacturing teams, ensuring every stage of production meets the highest standards of quality, compliance, and scientific rigor. From shop floor presence to final product release, your expertise will directly influence patient safety and product integrity while helping drive continuous improvement in a fast‑paced, purpose‑driven manufacturing environment.

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

• This will be a first shift role working 7:00 am - 3:30 pm, Monday - Friday

Key Responsibilities

• Provide proactive quality oversight through shop floor presence, walkthroughs, and real‑time manufacturing support.
• Review and approve master and executed batch records to ensure compliant clinical and commercial production.
• Partner with manufacturing teams to ensure consistent, compliant processes aligned with GMP requirements.
• Support media, buffer, cell expansion, upstream, downstream, and aseptic filling manufacturing operations.
• Lead deviation and corrective action investigations, ensuring thorough root cause analysis and effective remediation.
• Review alarms, data integrity, and electronic records to confirm accuracy and regulatory compliance.
• Support internal and external audits, inspections, and regulatory readiness activities.
• Provide quality expertise in manufacturing batch record design, review, and continuous improvement.
• Analyze quality metrics, identify trends, and communicate actionable insights to management.
• Lead or contribute to continuous improvement and quality system enhancement projects.

Essential Requirements

• Bachelor of Science degree in microbiology, chemistry, biochemistry, or a related scientific discipline.
• Minimum of five years of experience working in a regulated GMP manufacturing environment.
• Strong working knowledge and application of CFR, FDA, and EU regulatory requirements.
• Proven experience supporting or participating in FDA and EU regulatory inspections and audits.
• Hands‑on experience reviewing, authoring, and approving quality procedures and standard operating documents.
• Demonstrated ability to manage deviations, investigations, and corrective and preventive actions to closure.
• Strong analytical skills with the ability to interpret data, identify trends, and recommend compliant paths forward.
• Excellent written and verbal communication skills with the ability to collaborate effectively across functions.

Desirable Requirements

• Experience supporting viral gene therapies or orphan disease manufacturing programs.
• Experience leading or coordinating internal quality audits and inspection readiness activities.

Novartis Compensation And Benefit Summary

The salary for this position is expected to range between $43.08 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.

Why Novartis

Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture

Benefits and Rewards

Learn about all the ways we’ll help you thrive personally and professionally.

Read our handbook (PDF 30 MB)

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 & 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 [email protected] 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.