Senior QA Lead, GMP Biotech Manufacturing

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

Job summary

Miltenyi Biotec, Inc. in San Jose, CA, is seeking a QA professional to support the implementation of quality systems in a cGMP environment. The role emphasizes batch record review, material disposition, and QA oversight during manufacturing.

You will lead investigations, CAPA, change control activities, train staff, and coordinate release of cell-based products for clinical applications, working on-site in a GMP facility.

Qualifications

• Bachelor’s degree in life science or equivalent.
• 6–10 years of direct QA experience in GMP manufacturing.
• Experience in cell-based therapeutics or biopharma preferred.
• Strong oral and written communication skills.
• Schedule: 8:00am–5:00pm with irregular hours including weekends/nights.

Responsibilities

• Review batch records for final product, cell banks, in-process testing, QC release data, labeling and packaging.
• 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 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 of internal departments, external suppliers, and service providers.
• Review and approve validation/qualification packages (IQ/OQ/PQ).
• Train and provide QA guidance to internal groups on Quality Systems.
• Provide environmental monitoring support as needed.
• Other duties as assigned.

Skills

cGMPs knowledge

Communication skills

QA experience

Education

Bachelor’s degree in life science or equivalent

Job description

Miltenyi Biotec, Inc. in San Jose, CA, is seeking a QA professional to support the implementation of quality systems in a cGMP environment. The role emphasizes batch record review, material disposition, and QA oversight during manufacturing.

You will lead investigations, CAPA, change control activities, train staff, and coordinate release of cell-based products for clinical applications, working on-site in a GMP facility.