QA Operations Specialist - Shift Based

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 clickhere.

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