Onsite GMP Quality Assurance Specialist – Durham

Novartis AG; Durham (NC); On-site; USD 59,000 - 110,000; Full time

Benefits offered by this job

Health, life and disability benefits

401(k) with company match

Generous time off package

Job summary

Novartis AG in Durham, NC is seeking a Manufacturing Quality Assurance Specialist for an onsite first-shift role. You will partner with manufacturing teams to ensure every production stage meets GMP quality standards and supports regulatory readiness.

You will review batch records, manage deviations and CAPAs, and contribute to continuous improvement in a fast-paced environment. A BS in a scientific field and 5+ years in GMP manufacturing are required.

Qualifications

• Bachelor level degree in a related scientific discipline.
• Strong analytical skills with data interpretation abilities.
• Excellent written and verbal communication across functions.
• Experience reviewing and approving quality procedures and SOPs.
• Experience managing deviations, investigations and CAPAs to closure.
• Familiarity with CFR/FDA/EU regulatory requirements.

Responsibilities

• Provide proactive quality oversight through shop floor presence and real-time manufacturing support.
• Review and approve master and executed batch records for compliant production.
• Collaborate with manufacturing to ensure GMP-compliant processes.
• Support aseptic filling, media, buffers, and cell expansion operations.
• Lead deviation investigations and corrective action implementations.
• Monitor data integrity, alarms, and regulatory compliance; assist audits.

Skills

Analytical skills

Written communication

Verbal communication

CAPA management

Deviations & investigations

Education

Bachelor of Science in microbiology or related

Job description

Novartis AG in Durham, NC is seeking a Manufacturing Quality Assurance Specialist for an onsite first-shift role. You will partner with manufacturing teams to ensure every production stage meets GMP quality standards and supports regulatory readiness.

You will review batch records, manage deviations and CAPAs, and contribute to continuous improvement in a fast-paced environment. A BS in a scientific field and 5+ years in GMP manufacturing are required.