QA Operations Lead — Pharma Quality & Compliance

Novartis Group Companies; Carlsbad (CA); Vor Ort; USD 90.000 - 166.000; Vollzeit

Benefits dieser Stelle

Performance incentives

Equity awards

Health and life benefits

401(k) with company match

Paid time off and holidays

Zusammenfassung

Novartis Group of Companies in Carlsbad, CA is seeking a QA Operations Specialist to support manufacturing excellence, safeguard product quality, and drive compliance across site operations. The role involves coordinating with cross-functional teams, reviewing batch records and change controls, and ensuring ongoing cGMP compliance on a fast-paced site.

You will participate in regulatory inspections, contribute to continuous quality improvement, and provide quality training to strengthen the

Qualifikationen

• Bachelor's degree in Life Sciences, Chemistry, or related field.
• Minimum 3 years of GXPharmaceutical or API manufacturing operations.
• Minimum 2 years in a Quality Assurance role within a regulated environment.
• QA or QAQC experience in pharmaceutical environments with environmental monitoring and cleanliness zones.
• Experience reviewing quality documentation and supporting compliance in manufacturing operations.
• Experience supporting regulatory inspections, continuous improvement initiatives, or operational excellence projects.
• Proven ability to collaborate across functions and build strong working relationships.

Aufgaben

• Provide QA 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 and maintain site cGMP compliance.
• Deliver quality training and collaborate across teams to strengthen quality culture and performance.

Kenntnisse

Quality Assurance

Cross-functional collaboration

Regulatory inspections

Environmental monitoring

Audit readiness

Batch release review

Ausbildung

Bachelor's degree in Life Sciences or related

Jobbeschreibung

Novartis Group of Companies in Carlsbad, CA is seeking a QA Operations Specialist to support manufacturing excellence, safeguard product quality, and drive compliance across site operations. The role involves coordinating with cross-functional teams, reviewing batch records and change controls, and ensuring ongoing cGMP compliance on a fast-paced site.

You will participate in regulatory inspections, contribute to continuous quality improvement, and provide quality training to strengthen the