QA Operations Specialist - Shift Based
NovartisAbout the role
Band
Level 3
Job Description Summary
Location: Carlsbad, CaliforniaHelp 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.
Shift: This position will work a 12-hour rotating shift. Workdays will be Wednesday – Saturday with Wednesdays alternating. Shift hours are anticipated to be 8:00 am to 8:00 pm. Periodic mandatory overtime may be necessary to ensure process continuity and completion.
Job Description
Key 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 cGMP compliance.
Deliver quality training and collaborate across teams to strengthen quality culture and performance.
Essential Requirements
Bachelor’s degree in Life Sciences, Chemistry, or a related relevant degree.
Minimum 3 years of experience in GxP biopharmaceutical 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.
The salary for this position is expected to range between $43.08 and $80.00 per hour. The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the
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