Onsite GMP QA Specialist – Manufacturing

Regulatory Jobs; Durham (NC); On-site; USD 59,000 - 110,000; Full time

Job summary

Novartis is seeking a Manufacturing Quality Assurance Specialist to partner with manufacturing teams on the shop floor and ensure production meets quality, compliance, and scientific standards. The role directly impacts patient safety and product integrity while driving continuous improvement in a fast-paced manufacturing setting.

The position is based on-site in Durham, NC, with a first shift schedule and no relocation offered.

Qualifications

• Bachelor's degree in a scientific discipline is required.
• Five or more years of experience in a regulated GMP manufacturing environment.
• Strong knowledge of CFR, FDA, and EU regulatory requirements.
• Experience supporting FDA and EU inspections and audits.
• Experience authoring and approving quality procedures and SOPs.
• Ability to manage deviations, investigations, and CAPAs through closure.
• Strong data interpretation and trend identification skills.
• Excellent written and verbal communication across functions.

Responsibilities

• Provide proactive quality oversight with shop floor presence and real-time support.
• Review and approve master and executed batch records for compliant production.
• Collaborate with manufacturing to ensure GMP-compliant processes.
• Support media, buffers, cell expansion, upstream, downstream, and aseptic filling operations.
• Lead deviation investigations and root-cause analysis with remediation.
• Review alarms and data integrity to ensure regulatory compliance.
• Support internal and external audits and inspections.
• Contribute to quality system enhancements and process improvements.
• Analyze quality metrics and communicate actionable insights to management.
• Participate in continuous improvement initiatives.

Skills

Quality assurance

Data analysis

Regulatory knowledge

Communication

Audit readiness

Education

Bachelor of Science in microbiology, chemistry, biochemistry, or related science

Job description

Novartis is seeking a Manufacturing Quality Assurance Specialist to partner with manufacturing teams on the shop floor and ensure production meets quality, compliance, and scientific standards. The role directly impacts patient safety and product integrity while driving continuous improvement in a fast-paced manufacturing setting.

The position is based on-site in Durham, NC, with a first shift schedule and no relocation offered.