Senior QA Specialist — GMP & Manufacturing Excellence

Genentech; Holly Springs (NC); On-site; USD 94,000 - 175,000; Full time

Job summary

Genentech in Holly Springs, NC is seeking a Senior QA Specialist to ensure top-quality drug products and compliance across manufacturing and warehouse operations. You will embed quality into site design, support continuous improvement, and collaborate with cross-functional teams to meet global regulatory standards.

The role emphasizes risk-based operations, ALCOA+ data integrity, and readiness for regulatory inspections, with a focus on aseptic drug product manufacturing and device assembly at a

Qualifications

• Bachelor’s degree in a scientific or engineering discipline; Master’s or advanced degree strongly preferred.
• 6–8 years of experience in a GxP environment, with at least 3 years in an operational role within QA Operations, Manufacturing, or MSAT, specifically supporting sterile drug product manufacturing or device assembly.
• Experience with global regulatory standards and participating in regulatory inspections.
• Experience with digital tools and automated systems (e.g., SAP, MES) and ALCOA+ data integrity.

Responsibilities

• Manufacturing Process Oversight: oversee compounding, filling, visual inspection, device assembly, packaging, clean utility generation and distribution, and warehouse activities.
• Investigations & Deviations: serve as QA center of excellence for investigations, CAPAs and effectiveness checks; review/approve deviations.
• Compliance & Change Control: participate in risk assessments, review and approve change controls, optimizations, and minor equipment adjustments.
• Product Release & Incoming Goods: perform incoming goods release, intermediate & finished product release, and final disposition reviews.
• Quality Management: approve site procedures and drive SOP improvements.
• Inspection Support: support inspection readiness and regulatory inspections; review dossier sections.
• Cross-Functional QA Support: provide QA oversight for sample management, metrics, and data; extend QA guidance to MSAT, IT/OT,SC, Facilities/Engineering.

Skills

GxP environment

QA oversight

Root cause analysis

CAPA effectiveness

Regulatory inspections

ALCOA+ data integrity

Lean manufacturing

Education

Bachelor’s degree in a scientific or engineering discipline

Tools

SAP

MES

Job description

Genentech in Holly Springs, NC is seeking a Senior QA Specialist to ensure top-quality drug products and compliance across manufacturing and warehouse operations. You will embed quality into site design, support continuous improvement, and collaborate with cross-functional teams to meet global regulatory standards.

The role emphasizes risk-based operations, ALCOA+ data integrity, and readiness for regulatory inspections, with a focus on aseptic drug product manufacturing and device assembly at a