QA Operations Specialist Shift Based
Job Location:
Carlsbad, CA - USA
Hourly Salary:
Posted:
Application Deadline:
Vacancies:
Job Summary
Band
Level 3Job Description Summary
Location: 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.
Job Description
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
Bachelors 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 -based eligible employees will receive a comprehensive benefits package that includes healthlifeand disability benefits a 401(k) with company contribution and match and a variety of other addition employees are eligible for a generous time off package including vacation personal daysholidaysand other leaves.
To learn more about the culture rewards and benefits we offer our people clickhere.
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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 gender national origin age sexual orientation gender identity or expression marital or veteran status disability or any other legally protected status. We strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.
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 in order to perform the essential functions of a position please send an e-mail to call 1 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
Range
Skills Desired
Collaboration Data Integrity Leadership Operational ExcellenceRequired Experience:
IC
About Company
Novartis is a global healthcare company based in Switzerland that provides solutions to the evolving needs of patients worldwide.
