Novartis
Manufacturing Quality Assurance Specialist (1st Shift)
$90K–$166K
Durham · Full-time · Posted Oct 22, 2026
- Experience
- Minimum of five years in a regulated GMP manufacturing environment.
- Education
- Bachelor of Science degree in microbiology, chemistry, biochemistry, or a related scientific discipline.
About the job
Provides hands-on quality oversight for manufacturing operations, ensuring GMP compliance, product integrity, and readiness for release and regulatory inspection.
What you'll do
- Oversee manufacturing on the shop floor and review and approve batch records and electronic records.
- Lead deviation and corrective action investigations, including root cause analysis and remediation.
- Support audits, inspections, quality metrics, and continuous improvement projects.
What they ask for
- Bachelor of Science in microbiology, chemistry, biochemistry, or a related scientific discipline.
- Minimum of five years of experience in a regulated GMP manufacturing environment.
- Working knowledge of CFR, FDA, and EU regulatory requirements, with experience supporting FDA and EU inspections and audits.
- Experience reviewing, authoring, and approving quality procedures and standard operating documents; managing deviations, investigations, and corrective and preventive actions to closure.
Nice to have
- Experience supporting viral gene therapies or orphan disease manufacturing programs.
- Experience leading or coordinating internal quality audits and inspection readiness activities.
Pay
$43.08 and $80.00 per hour (base salary); $89,600.00 - $166,400.00 (base salary)
Tools
CFR, FDA, EU
Model-written summary · the original posting is authoritative