Senior QA Lead – Assembly & Packaging Excellence

NCBioImpact; Holly Springs (NC); Presencial; USD 115.000 - 213.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Relocation benefits

Descripción de la vacante

Genentech in Holly Springs, NC seeks a Principal QA Specialist to oversee quality for Assembly, Packaging and Warehouse, ensuring compliance with GMP and global regulations. You will lead quality systems, investigations, CAPA, and collaborate with MSAT, Operations, Engineering and QA to embed Quality by Design and continuous improvement in a high-volume aseptic environment.

Relocation benefits are available; the role offers a competitive salary range with discretionary bonus.

Formación

• Bachelor's degree in a scientific discipline; advanced degree preferred.
• 8–10 years in a GxP environment with device assembly/packaging experience.
• Experience with pre-filled syringes or autoinjectors is a plus.
• Strong GMP knowledge and regulatory inspection experience.

Responsabilidades

• Support Quality by Design and embed risk-based controls in assembly, packaging and warehouse operations.
• Approve procedures and drive continuous improvement for efficiency.
• Collaborate with MES and SAP teams to design recipes and master data.
• Define logic for Release by Exception to accelerate batch disposition.
• Support design reviews, FAT/SAT and commissioning activities.
• Lead investigations, CAPA, and deviations with root-cause analysis.
• Provide SME guidance for assembly/packaging and monitor trends for improvements.
• Support inspection readiness and regulatory dossier reviews.
• Participate in risk assessments and change controls.
• Oversee manufacturing process for device assembly, packaging, labeling, serialization and material movement.
• Act as QA owner for digital tools replacing paper documentation.

Conocimientos

GxP experience

Device assembly

Packaging experience

GMP knowledge

Regulatory inspections

SAP

MES

Quality systems

Educación

Bachelor's degree in a scientific discipline

Herramientas

SAP

MES

Descripción del empleo

Genentech in Holly Springs, NC seeks a Principal QA Specialist to oversee quality for Assembly, Packaging and Warehouse, ensuring compliance with GMP and global regulations. You will lead quality systems, investigations, CAPA, and collaborate with MSAT, Operations, Engineering and QA to embed Quality by Design and continuous improvement in a high-volume aseptic environment.

Relocation benefits are available; the role offers a competitive salary range with discretionary bonus.