Night-Shift Manufacturing QA Lead: GMP Compliance

U473 (FCRS = US473) Novartis Innovative Technologies Inc; North Carolina; On-site; USD 59,000 - 110,000; Full time

Job summary

Novartis is seeking a Manufacturing Quality Assurance Specialist for an onsite, third-shift role in Durham, NC. You will provide hands-on quality oversight across manufacturing processes, review batch records, and lead deviation investigations to ensure regulatory compliance and patient safety.

The role requires a BS in a relevant science, 5+ years in GMP manufacturing, and strong CFR/FDA/EU knowledge. Onsite 11:00 pm–7:30 am shift, with audits and continuous improvement responsibilities.

Qualifications

• Bachelor of Science in microbiology, chemistry, biochemistry, or related scientific discipline.
• Minimum of five years of experience in a regulated GMP manufacturing environment.
• Strong knowledge of CFR, FDA, and EU requirements; experience with FDA/EU inspections.

Responsibilities

• Provide proactive quality oversight on the shop floor with real-time manufacturing support.
• Review and approve batch records to ensure compliant production.
• Partner with manufacturing to maintain GMP-compliant processes.
• Lead deviation investigations and CAPA with root-cause analysis.
• Review data integrity and electronic records for regulatory readiness.
• Support audits, inspections, and regulatory readiness activities.

Skills

QA Oversight

GMP Knowledge

Audit Support

Root Cause Analysis

Documentation

Data Interpretation

Regulatory Compliance

Cross-functional Collaboration

Communication

Process Improvement

Education

B.S. in Microbiology, Chemistry, Biochemistry

Job description

Novartis is seeking a Manufacturing Quality Assurance Specialist for an onsite, third-shift role in Durham, NC. You will provide hands-on quality oversight across manufacturing processes, review batch records, and lead deviation investigations to ensure regulatory compliance and patient safety.

The role requires a BS in a relevant science, 5+ years in GMP manufacturing, and strong CFR/FDA/EU knowledge. Onsite 11:00 pm–7:30 am shift, with audits and continuous improvement responsibilities.