QA Operations Specialist – Carlsbad, 12‑Hr Shifts

Novartis; Carlsbad (CA); On-site; USD 59,000 - 110,000; Full time

Job summary

Novartis in Carlsbad, California, is seeking a QA Operations Specialist to support manufacturing, quality control, engineering, and supply chain operations. You will review records for batch release, SOPs, CAPAs, deviations, and change controls, while ensuring cGMP compliance and quality across site operations.

The role involves live batch record review, trend analysis, and driving continuous quality improvements with cross-functional teams in a fast-paced manufacturing environment.

Qualifications

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

Responsibilities

• Provide QA support for manufacturing, QC, engineering, and supply chain.
• Review and approve test records, SOPs, CAPAs, deviations, and change controls.
• Perform shop floor oversight and provide compliance guidance.
• Conduct live batch record review and inspect acceptable quality limits.
• Lead continuous quality improvement initiatives to enhance manufacturing quality and compliance.
• Support regulatory inspections and site cGMP readiness.
• Deliver quality training and foster a quality-focused culture.

Skills

QA oversight

Regulatory compliance

Cross-functional collaboration

Document review

GxP experience

Environmental monitoring

Education

Bachelor's degree in Life Sciences

Job description

Novartis in Carlsbad, California, is seeking a QA Operations Specialist to support manufacturing, quality control, engineering, and supply chain operations. You will review records for batch release, SOPs, CAPAs, deviations, and change controls, while ensuring cGMP compliance and quality across site operations.

The role involves live batch record review, trend analysis, and driving continuous quality improvements with cross-functional teams in a fast-paced manufacturing environment.