Manufacturing Quality Assurance Specialist
Novartis
On-site
Durham, NC
$39.03 - $72.50 USD yearly
Operations
Role Summary
Onsite Manufacturing Quality Assurance Specialist in Durham, you will be the quality partner from material release through aseptic filling and final product release. You’ll provide shop floor oversight, review batch records and alarms, guide investigations and corrective and preventive actions, and champion data-driven continuous improvement. You will collaborate across Production, Quality, and Technical Operations to uphold current Good Manufacturing Practice standards, support inspections, and translate complex regulations into clear decisions. This role offers the opportunity to impact therapies that can change lives.
Responsibilities
- Provide quality oversight for all manufacturing processes from material release to final product release.
- Conduct area walkthroughs, shop floor support, and batch record reviews to ensure compliance.
- Review and approve master and issued batch records, SOPs, and specifications for clinical and commercial manufacturing.
- Collaborate with manufacturing and quality teams to maintain cGMP standards and regulatory adherence.
- Lead projects to address quality gaps and drive continuous improvement in Operations or Quality Systems.
- Manage deviations and CAPA, ensuring thorough documentation and investigation of all incidents.
- Support internal, board of health, and self-inspections, providing guidance and training to team members.
Qualifications
- Bachelor’s degree preferably in microbiology, chemistry, or biochemistry with 5 years’ experience in health authority GMP regulated industry or Associate’s degree with 7 years’ experience health authority GMP regulated industry; preferably in pharma/biotech/med device.
- Experience with viral gene therapies and/or orphan disease indications is a plus.
- Knowledge and application of the CFR’s and cGMP’s and have been involved in regulatory inspections.
- Knowledge of FDA and EU regulations and experience in US and international regulatory agency inspections.
- Direct experience reviewing and/or authoring standard operating procedures and partnering with operations on product‚Äërelated investigations and deviations.
- Excellent oral and written communication skills with strong technical writing experience.
- Ability to synthesize data and summarize outcomes to provide recommendations on compliant path forward.
Skills
- Strong analytical and problem-solving abilities
- Technical writing and documentation proficiency
- Effective cross-functional collaboration
- Data-driven decision making
Education
- Bachelor’s degree in microbiology, chemistry, biochemistry, or related field; or Associate’s degree with equivalent GMP experience