Quality Assurance Associate
1 month ago
**About Karius**
- Karius is a venture-backed, life science startup that is transforming the way pathogens and other microbes are observed throughout the body. By unlocking the information present in microbial cell-free DNA, we're helping doctors quickly solve their most challenging cases, providing industry partners with access to 1000’s of biomarkers to accelerate clinical trials, discovering new microbes, and reducing patient suffering worldwide.
**Position Summary**
- The Quality Assurance Associate is an enthusiastic, self-motivated person with great communication skills. Along with the duties described below, this individual performs quality support to the internal quality framework including developing quality documentation and processes to support quality (e.g., audits, temperature excursions, CAPAs, deviations, etc.). The Quality Assurance Associate must demonstrate a high level of individual responsibility and accountability and possess the ability to perform to the requirements listed below. The QA Associate must be comfortable in a rapidly evolving Biotech start-up environment.
**Why Should You Join Us?**
- Karius aims to conquer infectious diseases through innovations around genomic sequencing and machine learning. The company’s platform is already delivering unprecedented insights into the microbial landscape, providing clinicians with a comprehensive test capable of identifying more than a thousand pathogens directly from blood, and helping industry accelerate the development of therapeutic solutions. The Karius test we provide today is one of the most advanced solutions available to physicians who aim to deliver better care to many otherwise ineffectively treated patients. Our test is the result of some incredible work done by our scientists, statisticians, engineers, and physicians, all driven by the same mission. You, as part of the Karius team, will be able to see how directly your work has a life-changing impact on people, and at scale.
**Reports to**: Manager, Quality Systems
**Location**: Redwood City, CA
**Primary Responsibilities**
- Supports / administers document control system, including revision and maintenance of lab documents to ensure compliance with CLIA regulations.
- Ensures that all documents are current, properly stored, and accessible to relevant personnel.
- Assists with personnel onboarding (introduction to controlled document system, personnel binders) and tracking of training, competency, and continuing education status.
- Ensures that documentation of training and competency records are prepared for review.
- Maintains standard operating procedures (SOP), work instructions and quality records for quality assurance systems.
- Ensure that all documents are current, properly stored, and accessible to relevant personnel.
- Review and improve existing quality procedure workflows, and identify areas of improvement for efficiency and compliance.
- Administers training materials and modules for the GLP activities.
- Support internal and external (regulatory) audits as required.
- Helps maintain Karius Quality records in a state of inspection readiness.
- Support continuous improvement initiatives including existing quality procedure workflows, aspects of the quality management system, etc.
- Provides administrative support of incident management system.
- Supports documentation needs of Karius core teams (routing validation packages, laboratory change control forms).
- Can be called on to assist with sample receipt and accessioning in accordance with established policies and regulations.
- Perform other responsibilities as specified by the Quality Systems Manager or Laboratory Director.
**What’s Fun About the Job?**
- Karius is operating at the edge of what is now known to be possible in infectious disease diagnostics. With that, comes a wave of new and incredible challenges and opportunities. To deliver on that value, you will be tapping into some of the most advanced technologies, architecting and innovating where the current solutions simply don't suffice. You will get to see how much your work really matters.
**Travel**: No travel required.
**Physical Requirements & Working Environment**
- Subject to extended periods of sitting and/or standing, vision to monitor and moderate noise levels. Work is generally performed in an office, lab or clinical environment. Hours and days may vary depending on operational needs. May be exposed to hazardous materials, blood specimens, and instruments. Some lifting (up to 25 pounds) may be necessary.
**Position Requirements**
- BS in a biological science or similar field of study preferred.
- Excellent organization skills allowing the coordination of multi-faceted QA activities.
- Strong attention to detail, organization, and teamwork skills.
- Ability to prioritize multiple tasks concurrently and meet deadlines.
- Excellent writing and digital literacy.
- Ability to proactively communicate in a consistent, clear and open
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