QA Operations Specialist - Shift Based

Regulatory Toolkit; Carlsbad (CA); On-site; USD 59,000 - 110,000; Full time

Job summary

Novartis in Carlsbad, California seeks a QA Operations Specialist to support manufacturing excellence, safeguard product quality, and drive site-wide compliance. You will collaborate with cross-functional teams to bring innovative therapies to patients and foster a culture of continuous improvement and quality leadership in a fast-paced environment.

The role includes a 12-hour rotating shift schedule, with specific days and overtime as needed, plus responsibilities such as batch record review,

Qualifications

• Bachelor’s degree in Life Sciences, Chemistry, or a related field.
• Minimum 3 years of experience in GxP biopharmaceutical or 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.

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.

Skills

Collaboration

Data Integrity

Leadership

Operational Excellence

Education

Bachelor’s degree in Life Sciences, Chemistry, or related field

Job description

Job 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.

Key Responsibilities

• Provide Quality Assurance support for manufacturing, quality control, engineering, and supply chain operations.
• Review and approvetest records for batch release, SOPs, CAPAs, Deviations, OOX investigations, Quality Risk Assessments, Quality Plans/Events, protocols, and change controls.
• Perform shop floor oversight andprovidecompliance guidance supporting operational decision-making.
• Conduct live batch record review and execute acceptable quality limit inspections.
• Supportcontinuousqualityimprovement initiatives that enhance manufacturing quality, compliance, and operational efficiency.
• Support regulatory inspection readiness, executeinspectionactivities, andmaintainongoingsitecGMPcompliance.
• Deliver quality training and collaborate across teams to strengthen quality culture and performance.

Essential Requirements

• Bachelor’s degree in Life Sciences, Chemistry, or a relatedrelevant degree.
• Minimum 3 years ofexperience inGxPbiopharmaceutical 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 cleanlinesszones.
• 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$43.08and$80.00perhour. The final salary offered isdeterminedbased on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors. Your compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards. US-based eligible employees will receive a comprehensive benefits package that includes health,lifeand disability benefits, a 401(k) with company contribution and match, and a variety of other benefits. In addition, employees are eligible for a generous time off package including vacation, personal days,holidaysand other leaves.

To learn more about the culture, rewards and benefits we offer our people click here.

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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 and 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 [e-mail] or call [phone] and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

Salary Range

$89,600.00 - $166,400.00

Skills Desired

Collaboration, Data Integrity, Leadership, Operational Excellence