Senior Quality Assurance Specialist I PC 1563

Miltenyi Biomedicine•San Jose, CA

15d•$120,988 - $142,405

About The Position

This position supports implementation of quality systems in compliance with cGMPs and company policies. The specialist provides quality assurance oversight for GMP manufacturing and helps coordinate the release of final cell-based therapeutic products for clinical applications. The role also supports quality investigations, audits, change control, deviation reporting, corrective and preventive action (CAPA), document review, validation and qualification, employee training, and environmental monitoring. The position is performed in a temperature-controlled facility, generally in a cleanroom setting. It involves frequent exposure to blood, viruses, bacteria, body fluids, and other tissues, and requires appropriate clothing and protective equipment when entering or leaving the laboratory. The stated schedule is 8:00 a.m. to 5:00 p.m., with irregular hours, weekends, and nights.

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.
Ability to work a schedule of 8:00 a.m. to 5:00 p.m. with irregular hours, weekends, and nights.
Ability to handle multiple tasks at a time and work at a rapid pace while maintaining attention to detail.
Ability to meet the role’s physical demands, including occasionally lifting or moving up to 35 pounds.

Nice To Haves

Experience in cell-based therapeutics or biopharmaceuticals.

Responsibilities

Review batch records for final product 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 and provide QA guidance to internal functional groups on Quality Systems.
Provide environmental monitoring support as needed.
Perform other duties as assigned.