Quality Assurance Associate | Karius

Quality Assurance Associate

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 process 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
•  Review documents associated with reagent qualification, lab deviation, change controls, CAPA and document retention.
•  Develop, implement and maintain standard operating procedures (SOP) for quality assurance system.
•  Review and improve existing quality procedure workflows, identify areas of improvement for efficiency and compliance.
•  Develop training materials and modules for the GLP function.
•  Support internal and external audits as required.
•  Support the preparation, coordination, and management of regulatory agency inspection.
•  Support continuous improvement initiatives including existing quality procedure workflows, aspects of quality management system, etc. 

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.
•  1 year of pertinent industry experience preferred.
•  Experience with deviations, lab investigations, Out of Specification and CAPAs preferred.
•  Strong knowledge of Microsoft Office applications.

Personal Qualifications
•  Excellent written and verbal communication skills.
•  Ability to proactively communicate in a consistent, clear and honest manner.
•  Flexible and adaptive in a frequently-changing environment. 

At Karius, we value a diverse and inclusive workplace and provide equal employment opportunity for all applicants and employees and are committed to honor and invest in the full diversity of people, in our hiring, recruiting and development of employees across the Company.  All qualified applicants for employment are encouraged to apply and will be considered without regard to an individual’s race, color, sex, gender identity and gender expression (including transgender individuals who are transitioning, have transitioned, or are perceived to be transitioning to the gender with which they identify), religion, age, national origin or ancestry, citizenship, physical or mental disability, medical condition, family care status, marital status, domestic partner status, sexual orientation, genetic information, military or veteran status, or any other basis protected by federal, state or local laws. If you are unable to submit your application due to a disability, please contact us at recruiting@kariusdx.com and we will accommodate qualified individuals with disabilities.  

Redwood City, CA