QA Specialist - Contract

Personalis, Inc(1 month ago)

Fremont, CAOnsiteTemporaryMedior$84,000 - $100,000Quality

About this role

The QA Specialist is a member of the Personalis Quality team responsible for supporting and maintaining the Quality Management System to ensure regulatory compliance. The role supports compliance with CLIA, CAP, ISO 15189, ISO 13485, 21 CFR 820 and related regulations and reports to the QA Director. This position operates with minimal supervision in a clinical laboratory environment and helps enable quality oversight for materials, documentation, audits, and continuous improvement.

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Required Skills

Quality Records
Documentation
Material Release
Supplier Management
Supply Chain
SOP Maintenance
Continuous Improvement
Quality Audits
Procedure Validation
Document Control

+10 more

Qualifications

Bachelor's Degree

About Personalis, Inc

personalis.com

Personalis is a genomics company focused on transforming the active management of cancer through comprehensive tumor and immune profiling. They deliver high‑resolution sequencing assays and proprietary bioinformatics — including whole‑exome and transcriptome sequencing, immune repertoire and HLA typing, and neoantigen discovery — to generate clinically actionable insights. Their products and services support precision oncology and immunotherapy development, enabling biomarker discovery, patient stratification, monitoring, and companion‑diagnostic research for pharma, diagnostic labs, and academic centers. Personalis emphasizes validated laboratory workflows and scalable informatics to produce accurate, regulatory‑grade data that accelerate clinical trials and personalized treatment decisions.