QA Operations Lead – Pharma Manufacturing

Novartis; Lavamünd; Vor Ort; EUR 78.000 - 145.000; Vollzeit

Benefits dieser Stelle

401(k) with company match

Health benefits

Paid time off

Zusammenfassung

Novartis in Carlsbad, CA is seeking a Quality Assurance professional to provide QA support across manufacturing, quality control, engineering, and supply chain operations. The role involves reviewing batch records, SOPs, CAPAs, and change controls to ensure regulatory compliance.

The position requires a life sciences degree and 3+ years in GxP bio/pharma manufacturing, plus 2+ years in QA within regulated environments. It offers a comprehensive benefits package and competitive salary.

Qualifikationen

• Bachelor's degree in Life Sciences, Chemistry, or a related relevant degree.
• Minimum 3 years in GxP bio pharmaceutical or API manufacturing operations.
• Minimum 2 years in a Quality Assurance role within a regulated environment.
• QA or QC experience in pharma environments with environmental monitoring and cleanliness zones.
• Experience reviewing quality documentation and supporting manufacturing compliance.
• Experience supporting regulatory inspections, continuous improvement, or operational excellence projects.
• Proven ability to collaborate effectively across functions.

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, Quality Plans/Events, protocols and change controls.
• Perform shop floor oversight and provide compliance guidance for decision-making.
• Conduct live batch record review and execute acceptable quality limit inspections.
• Support continuous quality improvement initiatives to enhance manufacturing quality and efficiency.
• Support regulatory inspection readiness and related activities; ensure GMP compliance.
• Deliver quality training and collaborate across teams to strengthen quality culture and performance.

Kenntnisse

Collaboration

Data Integrity

Leadership

Operational Excellence

Ausbildung

Bachelor's degree in Life Sciences/related field

Jobbeschreibung

Novartis in Carlsbad, CA is seeking a Quality Assurance professional to provide QA support across manufacturing, quality control, engineering, and supply chain operations. The role involves reviewing batch records, SOPs, CAPAs, and change controls to ensure regulatory compliance.

The position requires a life sciences degree and 3+ years in GxP bio/pharma manufacturing, plus 2+ years in QA within regulated environments. It offers a comprehensive benefits package and competitive salary.