GMP Manufacturing QA 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

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.