Senior Specialist, Quality Assurance Operations

Kyverna Therapeutics

Sr. Specialist in Quality Assurance Operations at Kyverna Therapeutics ensuring compliance in biotech product development.

Posted 5/2/2026contractEmeryville • California • 🇺🇸 United StatesSenior💰 $55 - $65 per hourWebsite

About the role

Key responsibilities & impact

Review executed batch records and associated documentation for accuracy and compliance
Support batch release and disposition activities
Must consistently meet production schedule release timelines
Ability to identify and escalate issues to Quality Management
Provide quality guidance on documentation discrepancies and compliance issues
Maintain and update vendor change notifications tracker
Assist with quality system processes, including deviations, change controls, CAPAs, and vendor change notifications
Ensure adherence to cGMP regulations, ICH guidelines, and Kyverna SOPs
Contribute to quality system enhancements and continuous process improvement initiatives
Perform additional duties as assigned

Requirements

What you’ll need

Bachelor’s degree in a life sciences discipline (e.g., biology, immunology, biochemistry) or equivalent experience
Minimum of 6 years of experience in Quality Assurance or a related role within biotech, pharmaceutical, or cell/gene therapy industries
Strong ability to manage multiple priorities in a fast-paced environment with keen attention to detail
Highly organized, self-motivated, and capable of working independently while following through on responsibilities
Excellent written and verbal communication skills, with the ability to collaborate effectively across all organizational levels

Benefits

Comp & perks

🌐 Worldwide ❌ Jobs You've Hidden ⭐️ Saved Jobs ✅ Applied Jobs ✉️ Email Alerts 👤 Account Kyverna Therapeutics Website LinkedIn All Job Openings 51 - 200 employees Founded 2019 🧬 Biotechnology 💊 Pharmaceuticals 🔬 Science 💰 $85M Series B on 2022-01 Biotechnology
Pharmaceuticals
Science Kyverna Therapeutics is a patient-centered, clinical-stage biopharmaceutical company focused on developing cell therapies for patients suffering from autoimmune diseases. The company is pioneering CAR T-cell therapies, leveraging the transformational power of T cells to potentially provide sustained, treatment-free remission for autoimmune conditions. Kyverna's lead CAR T-cell therapy candidate, KYV-101, is advancing through clinical trials targeting various autoimmune diseases, including multiple sclerosis, myasthenia gravis, systemic sclerosis, and lupus nephritis. Their pipeline features innovative chimeric antigen receptor (CAR) T-cell therapies in both autologous and allogeneic formats aimed at B cell-driven autoimmune diseases. Senior Specialist, Quality Assurance Operations 🔥 1 hour ago 🏢🏡 Emeryville – Hybrid 💵 $55 - $65 / hour ⏳ Contract/Temporary 🟠 Senior 🔧 QA Engineer (Quality Assurance) Apply Now Find Hiring Managers Customize resume for this job Report problem ☆ Save ☑️ Mark as applied ❌ Hide 📋 Description
Review executed batch records and associated documentation for accuracy and compliance
Support batch release and disposition activities
Must consistently meet production schedule release timelines
Ability to identify and escalate issues to Quality Management
Provide quality guidance on documentation discrepancies and compliance issues
Maintain and update vendor change notifications tracker
Assist with quality system processes, including deviations, change controls, CAPAs, and vendor change notifications
Ensure adherence to cGMP regulations, ICH guidelines, and Kyverna SOPs
Contribute to quality system enhancements and continuous process improvement initiatives
Perform additional duties as assigned 🎯 Requirements
Bachelor’s degree in a life sciences discipline (e.g., biology, immunology, biochemistry) or equivalent experience
Minimum of 6 years of experience in Quality Assurance or a related role within biotech, pharmaceutical, or cell/gene therapy industries
Strong ability to manage multiple priorities in a fast-paced environment with keen attention to detail
Highly organized, self-motivated, and capable of working independently while following through on responsibilities
Excellent written and verbal communication skills, with the ability to collaborate effectively across all organizational levels Apply Now 📊 Check your resume score for this job Improve your chances of getting an interview by checking your resume score before you apply. Check Resume Score 🌐 Worldwide Built by Lior Neu-ner. I'd love to hear your feedback — Get in touch via DM or support@remoterocketship.com Search Search Jobs by country Search jobs by city Search jobs by job title Search entry-level jobs Search junior-level jobs Search senior-level jobs Search jobs by tech stack Search jobs by contract type Search remote internships Search remote part-time jobs Remote jobs Anywhere in the World Companies Hiring Anywhere in the World Companies Hiring Sales People Anywhere in the World Companies Hiring Software Engineers Anywhere in the World Resources Advice Tips for finding remote jobs Interview questions and answers Resume examples Cover letter examples Post a job Affiliates Privacy policy Terms of service Job board SEO course AI Apply Copilot OpenClaw job finder Jobs by Country Remote jobs anywhere in the world (Worldwide remote jobs) Remote jobs United States Remote jobs Australia Remote jobs Brazil Remote jobs Canada Remote jobs France Remote jobs Ireland Remote jobs Germany Remote jobs Netherlands Remote jobs Spain Remote jobs UK Popular Jobs Remote data analyst jobs Remote customer support jobs Remote executive assistant jobs Remote marketing jobs Remote product designer jobs Remote product manager jobs Remote project manager jobs Remote recruiter jobs Remote sales jobs Remote software engineer jobs Jobs by Type Remote full-time jobs Remote part-time jobs Remote contract jobs Remote internship jobs Remote entry-level jobs Remote jobs with no experience required Remote junior jobs (1-3 years of experience) Digital nomad jobs Remote jobs with no degree required Freelance remote jobs Temporary remote jobs Remote jobs hiring now Stay at home mom jobs

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Hard Skills & Tools

batch record reviewcompliance documentationquality system processesdeviationschange controlsCAPAsvendor change notificationscGMP regulationsICH guidelinesquality assurance

Soft Skills

attention to detailorganizational skillsself-motivationindependencecollaborationcommunication skillsability to manage multiple prioritiesfast-paced environment adaptability