Manufacturing Quality Assurance Specialist
Novartis
August 24, 2026
On-site
Durham, NC
Operations
Key Responsibilities:
- Provide proactive quality oversight through shop floor presence, walkthroughs, and real-time manufacturing support.
- Review and approve master and executed batch records to ensure compliant clinical and commercial production.
- Partner with manufacturing teams to ensure consistent, compliant processes aligned with GMP requirements.
- Support media, buffer, cell expansion, upstream, downstream, and aseptic filling manufacturing operations.
- Lead deviation and corrective action investigations, ensuring thorough root cause analysis and effective remediation.
- Review alarms, data integrity, and electronic records to confirm accuracy and regulatory compliance.
- Support internal and external audits, inspections, and regulatory readiness activities.
- Provide quality expertise in manufacturing batch record design, review, and continuous improvement.
- Analyze quality metrics, identify trends, and communicate actionable insights to management.
- Lead or contribute to continuous improvement and quality system enhancement projects.
Essential Requirements:
- B.S. in microbiology, chemistry, biochemistry, or related scientific discipline.
- Minimum 5 years’ experience in a regulated GMP manufacturing environment.
- Working knowledge and application of CFR, FDA, and EU regulatory requirements.
- Proven experience supporting or participating in FDA and EU inspections and audits.
- Hands-on experience reviewing, authoring, and approving quality procedures and SOPs.
- Ability to manage deviations, investigations, and CAPA to closure.
- Strong analytical skills; excellent written and verbal communication; cross-functional collaboration.
Desirable Requirements:
- Experience in viral gene therapies or orphan disease manufacturing programs.
- Experience leading/coordinating internal quality audits and inspection readiness.
Compensation/Benefits:
- Salary expected range: $43.08–$80.00 per hour; includes performance-based cash incentive (and possible annual equity awards).
- US-based eligible employees receive a comprehensive benefits package (health, life/disability, 401(k) match, time off).
Location/Shift:
- Durham, NC onsite; 7:00 am–3:30 pm, Monday–Friday.
- Provide proactive quality oversight through shop floor presence, walkthroughs, and real-time manufacturing support.
- Review and approve master and executed batch records to ensure compliant clinical and commercial production.
- Partner with manufacturing teams to ensure consistent, compliant processes aligned with GMP requirements.
- Support media, buffer, cell expansion, upstream, downstream, and aseptic filling manufacturing operations.
- Lead deviation and corrective action investigations, ensuring thorough root cause analysis and effective remediation.
- Review alarms, data integrity, and electronic records to confirm accuracy and regulatory compliance.
- Support internal and external audits, inspections, and regulatory readiness activities.
- Provide quality expertise in manufacturing batch record design, review, and continuous improvement.
- Analyze quality metrics, identify trends, and communicate actionable insights to management.
- Lead or contribute to continuous improvement and quality system enhancement projects.
Essential Requirements:
- B.S. in microbiology, chemistry, biochemistry, or related scientific discipline.
- Minimum 5 years’ experience in a regulated GMP manufacturing environment.
- Working knowledge and application of CFR, FDA, and EU regulatory requirements.
- Proven experience supporting or participating in FDA and EU inspections and audits.
- Hands-on experience reviewing, authoring, and approving quality procedures and SOPs.
- Ability to manage deviations, investigations, and CAPA to closure.
- Strong analytical skills; excellent written and verbal communication; cross-functional collaboration.
Desirable Requirements:
- Experience in viral gene therapies or orphan disease manufacturing programs.
- Experience leading/coordinating internal quality audits and inspection readiness.
Compensation/Benefits:
- Salary expected range: $43.08–$80.00 per hour; includes performance-based cash incentive (and possible annual equity awards).
- US-based eligible employees receive a comprehensive benefits package (health, life/disability, 401(k) match, time off).
Location/Shift:
- Durham, NC onsite; 7:00 am–3:30 pm, Monday–Friday.