Hiring: Senior Quality Assurance Specialist I *PC 604 Company: Miltenyi Biotec Location: San Jose, CA Job Posted Time: 2026-09-12 14:04:47 Target Skills & Keywords : Quality Assurance About the job Experience: •5+ years of direct QA experience related to GMP Manufacturing in the biotechnology or pharmaceutical industry. Required Skills: •Perform review of batch records for intermediate or final product, cell banks including in-process testing, QC release testing data packages, labeling, packaging, and all supporting documentation •Inspect, review, and disposition raw materials, reagents and components •Facilitate investigations relating to manufactured products and raw materials •Provide QA oversight and QA on the floor support during GMP manufacturing operations •Conduct line clearances, in-process inspections, support final product packaging operations, etc. •Assist cross-functional teams with the initiation, investigation, and approval of Change Controls, Deviations, and CAPAs, providing critical QA input throughout. •Create, review and revise standard operating procedures, study protocols, reports, and other GxP documents as needed. •Coordinate the release of final cell-based therapeutic products for clinical and commercial applications. Qualifications: •Bachelor’s degree in life science; 5+ years of direct QA experience related to GMP Manufacturing in the biotechnology or pharmaceutical industry. •Strong knowledge of cGMPs and FDA, EMA, ICH, and ISO regulatory requirements. •Knowledge of Quality Systems, including Deviations, CAPAs, Change Controls, document control, and training processes. •Knowledge of batch record review, Good Documentation Practices (GDP), and product release activities. •Knowledge of validation and qualification activities, including IQ/OQ/PQ. •Strong investigation, problem-solving, and risk assessment skills. •Strong technical writing, document review, and communication skills. •Demonstrated capacity to provide QA oversight in a GMP manufacturing environment. •Demonstrated capacity to support audits, inspections, and regulatory readiness activities. •Demonstrated capacity to work effectively with cross-functional teams and provide QA guidance. Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!