QA Operations Specialist: Biopharma Quality & Compliance

Novartis; California (MO); On-site; USD 59,000 - 110,000; Full time

Job summary

Novartis in Carlsbad, California, is seeking a QA Operations Specialist to support manufacturing excellence, safeguard product quality, and drive compliance across site operations.

You will collaborate across functions to deliver life-changing therapies, participate in a 12-hour rotating shift, and contribute to continuous improvement initiatives. The role requires a Life Sciences degree and GxP/QA experience in regulated manufacturing.

Qualifications

• Bachelor's degree in Life Sciences, Chemistry, or related field.
• 3+ years of experience in GxP biopharmaceutical or API manufacturing operations.
• 2+ years in a Quality Assurance role within a regulated environment.
• Experience in pharma with environmental monitoring and cleanliness zones.
• Experience reviewing quality documentation and supporting manufacturing compliance.
• Experience supporting regulatory inspections, continuous improvement or operational excellence.
• Ability to collaborate across functions and build strong working relationships.

Responsibilities

• Provide Quality Assurance support for manufacturing, quality control, engineering, and supply chain operations.
• Review and approve test records for batch release, SOPs, CAPAs, Deviations, OOX investigations, QRA, quality plans/events, protocols, and change controls.
• Perform shop floor oversight and provide compliance guidance supporting operational decision-making.
• Conduct live batch record review and execute acceptable quality limit inspections.
• Support continuous quality improvement initiatives that enhance manufacturing quality, compliance, and operational efficiency.
• Support regulatory inspection readiness, execute inspection activities, and maintain site cGMP compliance.
• Deliver quality training and collaborate across teams to strengthen quality culture and performance.

Skills

GxP knowledge

Quality Assurance

Regulatory inspections

Cross-functional collaboration

Continuous improvement

Education

Bachelor's degree in Life Sciences, Chemistry, or related field

Job description

Novartis in Carlsbad, California, is seeking a QA Operations Specialist to support manufacturing excellence, safeguard product quality, and drive compliance across site operations.

You will collaborate across functions to deliver life-changing therapies, participate in a 12-hour rotating shift, and contribute to continuous improvement initiatives. The role requires a Life Sciences degree and GxP/QA experience in regulated manufacturing.