QA Operations Specialist - Shift Based

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

Benefits offered by this job

Comprehensive benefits package

401(k) with company contribution and 2

Generous time off

Job summary

Novartis near Carlsbad is seeking a QA Operations Specialist to support manufacturing, QC, and supply chain with rigorous GxP compliance. You will review batch release records, SOPs, CAPAs, deviations, and change controls while guiding cross-functional teams on quality decisions.

The role emphasizes live batch record review, regulatory inspection readiness, and ongoing cGMP adherence, with a focus on continuous quality improvement and training across sites.

Qualifications

• Bachelor’s degree in Life Sciences, Chemistry, or a related field.
• Minimum 3 years of GxP biopharmaceutical or API manufacturing operations.
• Minimum 2 years 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.

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.

Skills

GxP experience

QA collaboration

Quality documentation

Regulatory inspection support

Education

Bachelor's degree in Life Sciences

Job description

SummaryLocation: 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.About the RoleKey ResponsibilitiesProvide 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 RequirementsBachelor’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 click here.#LI-OnsiteWhy 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-cultureBenefits 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 AccommodationsThe 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.DivisionOperationsBusiness UnitProduction / ManufacturingLocationUSAStateCaliforniaSiteCarlsbadCompany / Legal EntityU469 (FCRS = US469) AAA USA Inc.Functional AreaQualityJob TypeFull timeEmployment TypeRegularShift WorkNo