Senior QA Specialist — GMP Cell Therapy

Miltenyi Biotec, Inc.; San Jose (CA); On-site; USD 121,000 - 142,000; Full time

Job summary

Miltenyi Biotec, Inc. is seeking a QA professional to provide oversight for cGMP manufacturing of cell and gene therapies in a San Jose facility. You will review batch records, approve material releases, and support QA on the manufacturing floor to ensure regulatory compliance.

The role requires a life sciences degree and 5+ years in GMP QA, with experience in audits and CAPAs. On-site work with a comprehensive benefits package is offered.

Qualifications

• Bachelor’s degree in life science.
• 5+ years of direct QA experience in GMP manufacturing.
• Experience with cell-based therapeutics or biopharmaceuticals.
• Experience supporting internal/external audits and inspections.

Responsibilities

• Review batch records for intermediate or final product, cell banks including in-process testing and release data.
• Inspect, review, and disposition raw materials, reagents and components.
• Facilitate investigations relating to manufactured products and raw materials.
• Provide QA oversight on the floor during GMP manufacturing operations.
• Initiate, investigate, and approve Change Controls, Deviations, and CAPAs.
• Create, review and revise SOPs, study protocols, and GxP documents.
• Coordinate release of final cell-based therapeutic products for clinical and commercial use.
• Participate in audits and audit reports; review validation/qualification packages.

Skills

cGMP knowledge

QA oversight

Documentation

Regulatory compliance

Cross-functional collaboration

Education

Bachelor’s degree in life science

Job description

Miltenyi Biotec, Inc. is seeking a QA professional to provide oversight for cGMP manufacturing of cell and gene therapies in a San Jose facility. You will review batch records, approve material releases, and support QA on the manufacturing floor to ensure regulatory compliance.

The role requires a life sciences degree and 5+ years in GMP QA, with experience in audits and CAPAs. On-site work with a comprehensive benefits package is offered.