Miltenyi Biotec · 6 hours ago
Senior Quality Assurance Specialist I *PC 583
San Jose, California, United States
Full-time
Onsite
Mid, Senior Level
$119K/yr - $140K/yr
5+ years expMiltenyi Biotec is a company dedicated to revolutionizing biomedical research, and they are seeking a Senior Quality Assurance Specialist I to maintain quality systems and ensure GMP compliance for operations related to clinical supplies and commercial production. The role involves authoring and reviewing documentation, providing QA support, conducting audits, and leading investigations related to manufacturing processes.
BioinformaticsBiotechnologyHealth CareMedical
Responsibilities
Author, review, and revise relevant documentation, such as SOPs, Policies and Standards related to GMP compliance requirements
Provide on-floor QA support, some weekends and evenings may apply
Perform lot disposition of clinical/commercial product
Conduct review of batch production records and supporting batch documentation, such as quality control testing data and equipment maintenance and calibration records
Lead investigations and manage quality records related to manufacturing of CGT products
Assist in internal compliance and external (supplier) audits as assigned
May assist in hosting audits conducted by clients and regulatory agencies
Lead in developing and maintaining quality metrics
Serve as an internal interface with customers on GMP contract manufacturing projects
Support receipt, inspection and release of raw materials and components
Qualification
Required
Bachelor's Degree in life sciences with QA experience related to GMP Manufacturing in the biotechnology or pharmaceutical industry
Must have strong knowledge of cGMPs
Must have excellent oral and written communication skills
5+ years of related experience and/or training
Previous and substantial GMP experience is required
Prior knowledge of word processing, database management, and record-keeping
Some nights and weekends may be required
Preferred
Experience in cell-based therapeutics or biopharmaceuticals
Benefits
Health, vision, and dental insurance
401(k) plan
Company
Miltenyi Biotec
Design, development, manufacture, integration of products empowering the advancement of biomedical research and enable cell and gene therapy
Founded in 1989Bergisch Gladbach, Nordrhein-Westfalen, DEU
1001-5000 employees
H1B Sponsorship
Miltenyi Biotec has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (2)
2023 (1)
2022 (1)
2020 (2)
Funding
Current Stage
Late StageLeadership Team
Markus Weiss
President & CFO Miltenyi Biotec North America
Norbert Henschel
CFO / Managing Director
Recent News
2025-10-06
2025-09-24
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