Senior QA Specialist for GMP Cell Therapy (On-Site)

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

Benefits offered by this job

Health, Vision, & Dental Insurance

401(k) Plan

Job summary

Miltenyi Biotec is seeking a QA professional to support the implementation of quality systems in compliance with cGMPs. The role involves reviewing batch records, materials disposition, and facilitating investigations to ensure product quality.

The responsibilities include providing QA oversight during GMP manufacturing, participating in audits, and coordinating release of cell-based therapies while maintaining SOPs and CAPA processes.

Qualifications

• Bachelor’s degree in life science or equivalent.
• 6–10 years of QA experience related to GMP manufacturing.
• Strong knowledge of cGMPs.
• Excellent oral and written communication skills.

Responsibilities

• Review batch records for final product, cell banks and in-process testing data packages.
• Inspect, review, and disposition raw materials, reagents and components.
• Facilitate investigations relating to manufactured products and raw materials.
• Provide QA oversight during GMP manufacturing operations.
• Conduct line clearances, in-process inspections, support final product packaging operations.
• Support the Change Control, Deviation Reporting and CAPA programs.
• Review and revise SOPs, study protocols and reports.
• Coordinate release of final cell-based therapeutic products for clinical applications.
• Participate in audits and complete audit reports as needed.
• Review and approve validation/qualification packages (IQ/OQ/PQ) and reports.
• Train and provide QA guidance on Quality Systems.

Skills

cGMP knowledge

Communication skills

QA experience

Education

Bachelor’s degree in life science or equivalent

Job description

Miltenyi Biotec is seeking a QA professional to support the implementation of quality systems in compliance with cGMPs. The role involves reviewing batch records, materials disposition, and facilitating investigations to ensure product quality.

The responsibilities include providing QA oversight during GMP manufacturing, participating in audits, and coordinating release of cell-based therapies while maintaining SOPs and CAPA processes.