Chemistry
Operations
Leadership
Innovation
Cleanliness
Cancer Care
Supply Chain
Life Sciences
Investigation
Risk Analysis
Collaboration
Change Control
Pharmaceuticals
Quality Control
Quality Culture
Safety Assurance
Quality Assurance
Operational Excellence
Operational Efficiency
Product Quality (QA/QC)
Manufacturing Operations
Environmental Monitoring
Continuous Improvement Process
Active Pharmaceutical Ingredients
Frontline Decision-Making Autonomy
Continuous Quality Improvement (CQI)
Application Programming Interface (API)
Corrective And Preventive Action (CAPA)
At least 3 years
$166,400 / yr
Posted 3 days ago
This role is STARs-friendly: Skilled Through Alternative Routes.
59% STARs in role.
Description:
Summary
Location: Carlsbad, California 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. 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.
About the Role
Key Responsibilities
To learn more about the culture, rewards and benefits we offer our people click here.
#LI-Onsite
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients' lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture
Benefits and Rewards: Learn about all the ways we'll help you thrive personally and professionally.
Read our handbook (PDF 30 MB)
EEO Statement:
The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status.
Accessibility & Reasonable Accommodations
The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or to perform the essential functions of a position, please send an e-mail to [email protected] or call +1(877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
Location: Carlsbad, California 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. 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.
About the Role
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, execut e inspection activities, and maintain ongoing site c G MP compliance.
- Deliver quality training and collaborate across teams to strengthen quality culture and performance.
- 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 zone s .
- 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.
To learn more about the culture, rewards and benefits we offer our people click here.
#LI-Onsite
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients' lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture
Benefits and Rewards: Learn about all the ways we'll help you thrive personally and professionally.
Read our handbook (PDF 30 MB)
EEO Statement:
The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status.
Accessibility & Reasonable Accommodations
The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or to perform the essential functions of a position, please send an e-mail to [email protected] or call +1(877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
Posting ID: REQ-10083266_crt:1789039067145