Manufacturing Quality Assurance Specialist

Novartis•Durham, CA

1d•Onsite

About The Position

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.

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.

Nice To Haves

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

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.