Principal QA Specialist, Multi-Dose Pens (Aseptic)

F. Hoffmann-La Roche AG; Holly Springs (NC); On-site; USD 115,000 - 213,000; Full time

Benefits offered by this job

Relocation assistance

Job summary

Genentech in Holly Springs, NC is building a state-of-the-art drug product manufacturing site. The Principal QA Specialist will oversee quality for cartridge filling, inspections, assembly and packaging, ensuring compliance with GMP and regulatory standards.

You will collaborate with MSAT, Operations, Quality and global teams to embed Quality by Design and continuous improvement into site processes, driving excellence in aseptic manufacturing.

Qualifications

• 8–10 years in a GxP environment.
• At least 4 years in cartridge sterile drug product manufacturing.
• Advanced GMP knowledge with global regulatory inspections (FDA, EMA).
• Expertise in Quality Assurance, including deviation management, CAPA, and release processes.
• Experience with SAP and MES; translate business processes into digital recipes.

Responsibilities

• Oversee quality for cartridge filling, inspections, assembly and packaging.
• Approve procedures and drive continuous improvement.
• Design Release by Exception logic for accelerated batch disposition.
• Support equipment design reviews, FAT/SAT and commissioning pre-PQ.
• Lead investigations and CAPA, identifying root causes.

Skills

Quality mindset

Regulatory compliance

Technical writing

Problem solving

Education

Bachelor’s degree in a scientific discipline

Tools

SAP

MES

Job description

Genentech in Holly Springs, NC is building a state-of-the-art drug product manufacturing site. The Principal QA Specialist will oversee quality for cartridge filling, inspections, assembly and packaging, ensuring compliance with GMP and regulatory standards.

You will collaborate with MSAT, Operations, Quality and global teams to embed Quality by Design and continuous improvement into site processes, driving excellence in aseptic manufacturing.