QA Operations Specialist - Shift Based
Novartis•Carlsbad, CA
•Onsite
About The Position
Help reimagine cancer care by ensuring the quality and compliance behind innovative Radioligand Therapies that are transforming patient outcomes. As a QA Operations Specialist at Novartis, you will play a critical role in supporting manufacturing excellence, safeguarding product quality, and driving compliance across site operations. Working closely with cross-functional teams, you will help bring life-changing therapies to patients while contributing to a culture of continuous improvement, operational excellence, and quality leadership in a fast-paced manufacturing environment.
Requirements
- Bachelor’s degree in Life Sciences, Chemistry, or a related relevant degree.
- Minimum 3 years of experience in G xP bio pharmaceutical or active pharmaceutical ingredient (API) manufacturing operations.
- Minimum 2 years of experience in a Quality Assurance role within a regulated environment.
- Quality Assurance or Quality Control experience in pharmaceutical environments with environmental monitoring and cleanliness zones.
- Experience reviewing quality documentation and supporting compliance within manufacturing operations.
- Experience supporting regulatory inspections, continuous improvement initiatives, or operational excellence projects.
- Proven ability to collaborate effectively across functions and build strong working relationships.
Nice To Haves
- Collaboration
- Data Integrity
- Leadership
- Operational Excellence
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, Quality Risk Assessments, 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 ongoing site c G MP compliance.
- Deliver quality training and collaborate across teams to strengthen quality culture and performance.
Benefits
- health
- life and disability benefits
- a 401(k) with company contribution and match
- vacation
- personal days
- holidays
- other leaves
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
