Jobs at Miltenyi Biotec

Lead QA for the San Jose CDMO site, overseeing Quality Operations, QMS, CMC quality, inspections, audits, batch release, supplier quality, technical transfers and regulatory submissions. Build and develop a high-performing QA team, ensure inspection readiness, drive compliance with international GxP and pharmacopeial standards, and support client commercialization programs and global quality initiatives.

Perform development, qualification, and execution of environmental monitoring and microbiological QC assays for GMP biologics manufacturing. Lead EM investigations, trend and report EM data, create SOPs and GMP documentation, train staff, maintain equipment per cGMP, and support QA, manufacturing, and audits.

Provide on-the-floor QA support for manufacturing, packaging, and warehouse operations to ensure cGMP compliance. Perform real-time line checks, AQL inspections, batch record review, product disposition, deviation/CAPA support, investigations, and release activities. Support audits, continuous improvement, and 24/7 shift operations in a controlled biomanufacturing environment.