Senior Quality Assurance Specialist I PC 1563

Miltenyi Biotec•San Jose, CA

14d

About The Position

This position supports the implementation of quality systems in compliance with cGMPs and company policies. The role provides quality assurance oversight for GMP manufacturing and supports the release of cell-based therapeutic products for clinical applications. It also supports quality-system processes, including change control, deviation reporting, CAPA, audits, validation and qualification, training, and environmental monitoring.

Requirements

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

Nice To Haves

Experience in cell-based therapeutics or biopharmaceuticals is preferred.

Responsibilities

Review batch records for final products and cell banks, including in-process testing, QC release testing data packages, labeling, packaging, and supporting documentation.
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 and in-process inspections, and support final product packaging operations.
Support implementation of the Change Control, Deviation Reporting, and CAPA programs.
Review and revise standard operating procedures, 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, and complete audit reports as needed.
Review and approve validation and qualification packages, including IQ, OQ, and PQ protocols and reports, as necessary.
Train internal functional groups and provide QA guidance on Quality Systems.
Provide environmental monitoring support as needed.
Perform other duties as assigned.