QA Operations Specialist - Shift Based

Novartis Group Companies; Carlsbad (CA); On-site; USD 90,000 - 166,000; Full time

Benefits offered by this job

Performance incentives

Equity awards

Health and life benefits

401(k) with company match

Paid time off and holidays

Job summary

Novartis Group of Companies in Carlsbad, CA is seeking a QA Operations Specialist to support manufacturing excellence, safeguard product quality, and drive compliance across site operations. The role involves coordinating with cross-functional teams, reviewing batch records and change controls, and ensuring ongoing cGMP compliance on a fast-paced site.

You will participate in regulatory inspections, contribute to continuous quality improvement, and provide quality training to strengthen the

Qualifications

• Bachelor's degree in Life Sciences, Chemistry, or related field.
• Minimum 3 years of GXPharmaceutical or API manufacturing operations.
• Minimum 2 years in a Quality Assurance role within a regulated environment.
• QA or QAQC experience in pharmaceutical environments with environmental monitoring and cleanliness zones.
• Experience reviewing quality documentation and supporting compliance in manufacturing operations.
• Experience supporting regulatory inspections, continuous improvement initiatives, or operational excellence projects.
• Proven ability to collaborate across functions and build strong working relationships.

Responsibilities

• Provide QA support for manufacturing, quality control, engineering, and supply chain operations.
• Review and approve test records for batch release, SOPs, CAPAs, Deviations, OOX investigations, QRA, 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 and maintain site cGMP compliance.
• Deliver quality training and collaborate across teams to strengthen quality culture and performance.

Skills

Quality Assurance

Cross-functional collaboration

Regulatory inspections

Environmental monitoring

Audit readiness

Batch release review

Education

Bachelor's degree in Life Sciences or related

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 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 GXPharmaceutical 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.

Salary and Compensation

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.

• performance-based cash incentive
• eligibility to be considered for annual equity awards
• health, life and disability benefits
• 401(k) with company contribution and match
• variety of other benefits
• generous time off package including vacation, personal days, holidays and other leaves

Salary Range $89,600.00 - $166,400.00

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.

Skills Desired

Collaboration, Data Integrity, Leadership, Operational Excellence