Manufacturing Quality Assurance Specialist (1st Shift)

About the role

Novartis is looking for a Manufacturing Quality Assurance Specialist for its Durham, NC site, working the first shift (8:00 pm to 4:30 pm, Monday to Friday) in an onsite role. The specialist acts as a hands-on partner to manufacturing teams, ensuring every stage of production meets quality, compliance and scientific standards, from shop floor presence to final product release.

Key responsibilities

• Provide proactive quality oversight through shop floor presence, walkthroughs and real-time manufacturing support.
• Review and approve master and executed batch records for compliant clinical and commercial production.
• Partner with manufacturing teams to keep processes aligned with GMP requirements, covering media, buffer, cell expansion, upstream, downstream and aseptic filling operations.
• Lead deviation and corrective action investigations with thorough root cause analysis.
• Review alarms, data integrity and electronic records for accuracy and regulatory compliance.
• Support internal and external audits, inspections and regulatory readiness.
• Contribute to batch record design, quality metrics analysis and continuous improvement projects.

Required profile

• Bachelor of Science in microbiology, chemistry, biochemistry or a related scientific discipline.
• At least five years of experience in a regulated GMP manufacturing environment.
• Proven experience supporting or taking part in FDA and EU regulatory inspections and audits.
• Hands-on experience reviewing, authoring and approving quality procedures and SOPs.
• Ability to manage deviations, investigations and CAPA to closure.
• Desirable: experience with viral gene therapies or orphan disease programs, and leading internal quality audits and inspection readiness.

Required skills

• Strong knowledge of CFR, FDA and EU regulatory requirements.
• Good Manufacturing Practices (GMP), Quality Assurance (QA), Quality Control (QC) and Quality Management Systems (QMS).
• Data integrity, SOPs, statistical process control (SPC) and regulatory compliance.

What we offer

• Expected pay of $43.08 to $80.00 per hour (annual range $89,600 to $166,400), with a performance-based cash incentive and possible equity awards.
• Health, life and disability benefits, 401(k) with company contribution and match.
• Vacation, personal days, holidays and other leaves.