QA Operations Specialist - Shift Based

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

Job summary

Novartis in Carlsbad, California, is seeking a QA Operations Specialist to support manufacturing, quality control, engineering, and supply chain operations. You will review records for batch release, SOPs, CAPAs, deviations, and change controls, while ensuring cGMP compliance and quality across site operations.

The role involves live batch record review, trend analysis, and driving continuous quality improvements with cross-functional teams in a fast-paced manufacturing environment.

Qualifications

• Bachelor's degree in Life Sciences, Chemistry, or related field.
• Minimum 3 years of experience in GxP biopharmaceutical or API manufacturing.
• Minimum 2 years in a Quality Assurance role within a regulated environment.
• Experience with environmental monitoring and cleanliness zones.
• Experience reviewing quality documentation and supporting manufacturing compliance.
• Experience supporting regulatory inspections or operational excellence projects.
• Ability to collaborate across functions and build relationships.

Responsibilities

• Provide QA support for manufacturing, QC, engineering, and supply chain.
• Review and approve test records, SOPs, CAPAs, deviations, and change controls.
• Perform shop floor oversight and provide compliance guidance.
• Conduct live batch record review and inspect acceptable quality limits.
• Lead continuous quality improvement initiatives to enhance manufacturing quality and compliance.
• Support regulatory inspections and site cGMP readiness.
• Deliver quality training and foster a quality-focused culture.

Skills

QA oversight

Regulatory compliance

Cross-functional collaboration

Document review

GxP experience

Environmental monitoring

Education

Bachelor's degree in Life Sciences

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.

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, 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 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, life and 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, holidays and other leaves.

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

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