Personalis, Inc. · 1 day ago
QA Specialist - Contract
Fremont, CA
Contract
Onsite
Entry, Mid Level
$42/hr - $50/hr
2+ years expPersonalis, Inc. is transforming cancer management through personalized testing. The QA Specialist will support the Quality Management System and ensure compliance with various regulations while collaborating with different teams to maintain quality standards.
BiotechnologyGeneticsHealth CareHealth Diagnostics
Responsibilities
Review of Quality Records / Batch Records for compliance with internal procedures and contracts
Provide guidance and support to staff on Good Documentation Practices
Inspect and release raw and in-process materials in compliance with internal specifications and procedures
Represent Quality at the Supplier and Material Quality Review Board
Collaborate with Supply Chain and Materials Management to establish material specifications
Maintain policies and SOPs to ensure the effectiveness of Material Qualification processes
Help drive continuous improvement initiatives in support of Quality Systems, as applicable
Execute study specific Quality Audits in support of clinical trial partnerships, as applicable
Update procedures to reflect changes to QMS including validation of eQM, as applicable
Ensure documentation and data related to the requirements of the Quality System are controlled
Assist in the investigation and root cause analysis teams for CAPAs, deviations and non-conformances
Support audits for licensure and accreditation documents submission
Additional Quality related duties as assigned
Qualification
Required
Bachelor's degree with a minimum of 2+ years in a Quality role
Ability to compile data and summarize results
Excellent written and verbal communication skills
Experience with ISO Standards and FDA-regulated environment highly desirable
Experience in quality system methodologies
Strong desire to work in a demanding, high-energy, hands-on environment
Expert level use of Word, Excel, and Google Suite; experience with electronic quality management systems
Company
Personalis, Inc.
At Personalis, we are transforming the active management of cancer through breakthrough personalized testing.
201-500 employees
H1B Sponsorship
Personalis, Inc. 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 (6)
2024 (10)
2023 (17)
2022 (19)
2021 (12)
2020 (7)
Funding
Current Stage
Public CompanyTotal Funding
$311.25MKey Investors
MerckTempusLightspeed Venture Partners
2024-12-19Post Ipo Equity· $50M
2024-08-16Post Ipo Equity· $36.15M
2021-01-27Post Ipo Equity· $150.1M
Leadership Team
Aaron Tachibana
Chief Financial Officer
Christian Haudenschild
Senior Vice President
Recent News
2026-01-09
2026-01-06
Company data provided by crunchbase