QC Specialist PC 642

Miltenyi Biomedicine • San Jose, CA

22h • $47 - $56

About The Position

The QC Specialist is responsible for ensuring the compliant execution, oversight, and continuous improvement of Quality Control activities supporting Cell and Gene Therapy (CGT) products under cGMP conditions. This role provides subject matter expertise in analytical testing, quality event management, and method lifecycle activities. The position requires strong technical knowledge, regulatory awareness, and the ability to lead complex investigations, cross-functional initiatives, and inspection readiness activities.

Requirements

• Bachelor’s degree (B.S.) in the life sciences field or related education; 5+ years’ experience in a laboratory or cGMP/cGTP environment (clinical, microbiology, hematology, immunology, or Quality control).
• Experience with quality systems including change controls, deviations, CAPAs, GxP regulations, and standards.
• Hands on experience with biopharmaceutical Quality Control, flow cytometry, and proactively managing laboratory materials.
• Demonstrate ability to effectively communicate with cross functional groups.
• Experience and knowledgeable in laboratory techniques including PCR, ELISA, and Cell-based assays.

Responsibilities

• Coordinate the initiation, investigation, and timely closure of QC related quality events including deviations, OOS/OOT investigations, CAPAs, and MOCs.
• In coordination with management, ensure compliance with cGMP, ALCOA+ data integrity principles, and 21 CFR Part 11 requirements.
• Review analytical data executed laboratory documentation and provide suggestions for improvement.
• Perform hands-on testing as needed for training, troubleshooting, or operational support.
• Author and review method validation protocols and reports in accordance with regulatory guidance.
• Coordinate development, revision, and approval of SOPs, protocols, reports, and GMP documentation.
• Develop and maintain QC metrics and data trending programs to identify shifts, variability, and emerging risks.
• Drive process improvements and implement approved changes to enhance efficiency and compliance.
• Assist in QC scheduling, resource planning, and capacity modeling.
• Oversee contract testing laboratories including sample ship out, method transfer, performance monitoring, and quality event management.
• Other duties as assigned.

Benefits

• In addition to your salary, the Company offers a comprehensive benefits package, including health, vision, and dental insurance, as well as a 401(k) plan.
• All benefits are subject to eligibility requirements.
• Certain positions may also be eligible for additional compensation such as bonuses or commissions.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 501-1,000 employees