QA Operations Specialist: Biopharma Quality & Compliance

Novartis; Carlsbad (NM); Presencial; USD 90.000 - 166.000; Jornada completa

Descripción de la vacante

Novartis is seeking a QA Operations Specialist in Carlsbad, CA. You will ensure quality and compliance across site operations within a 12-hour rotating shift (Wed–Sat, with Wednesdays alternating).

The role supports manufacturing excellence, product quality, and regulatory readiness while driving continuous improvement and operational excellence. Required: a Bachelor’s degree in Life Sciences or related field, plus 3+ years in GxP biopharma or API manufacturing and 2+ years QA experience in a

Formación

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

Responsabilidades

• 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 perform 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 cGMP compliance.
• Deliver quality training and collaborate across teams to strengthen quality culture and performance.

Conocimientos

Collaboration across functions

GxP biopharma

Regulatory inspections support

Educación

Bachelor’s degree in Life Sciences

Descripción del empleo

Novartis is seeking a QA Operations Specialist in Carlsbad, CA. You will ensure quality and compliance across site operations within a 12-hour rotating shift (Wed–Sat, with Wednesdays alternating).

The role supports manufacturing excellence, product quality, and regulatory readiness while driving continuous improvement and operational excellence. Required: a Bachelor’s degree in Life Sciences or related field, plus 3+ years in GxP biopharma or API manufacturing and 2+ years QA experience in a