Manufacturing Quality Assurance Specialist (1st Shift)

Regulatory Toolkit; 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

Job Description Summary

Quality is not just a checkpoint here-it is the promise we make to patients. As a Manufacturing Quality Assurance Specialist at Novartis, you will be a hands-on partner to manufacturing teams, ensuring every stage of production meets the highest standards of quality, compliance, and scientific rigor. From shop floor presence to final product release, your expertise will directly influence patient safety and product integrity while helping drive continuous improvement in a fast-paced, purpose-driven manufacturing environment.

Location:

• This position will be located in Durham, NC and will be an onsite role.


• Novartis is unable to offer relocation support for this role: please only apply if this location is accessible for you.

Shift:

• This will be a first shift role working 8:00 pm - 4:30 pm, Monday - Friday

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:

• Bachelor of Science degree in microbiology, chemistry, biochemistry, or a related scientific discipline.


• Minimum of five years of experience working in a regulated GMP manufacturing environment.


• Strong working knowledge and application of CFR, FDA, and EU regulatory requirements.


• Proven experience supporting or participating in FDA and EU regulatory inspections and audits.


• Hands-on experience reviewing, authoring, and approving quality procedures and standard operating documents.


• Demonstrated ability to manage deviations, investigations, and corrective and preventive actions to closure.


• Strong analytical skills with the ability to interpret data, identify trends, and recommend compliant paths forward.


• Excellent written and verbal communication skills with the ability to collaborate effectively across functions.

Desirable Requirements:

• Experience supporting viral gene therapies or orphan disease manufacturing programs.


• Experience leading or coordinating internal quality audits and inspection readiness activities.

Novartis Compensation and Benefit Summary:

The salary for this position is expected to range between $43.08 and $80.00 per hour.

The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors.

Your compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards.

US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits. In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves.

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EEO Statement:

The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status.

Accessibility and reasonable accommodations

The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or to perform the essential functions of a position, please send an e-mail to [e-mail] or call [phone] and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

Salary Range

$89,600.00 - $166,400.00

Skills Desired

Collaboration, Communication, Data Integrity, Good Manufacturing Practices (GMP), Internal Quality Auditing, Managing Ambiguity, Operational Excellence, Quality Assurance (QA), Quality Compliance, Quality Control (QC), Quality Management Systems (QMS), Regulatory Compliance, Standard Operating Procedure (SOP), Statistical Process Control (SPC)