Quality Assurance Associate

Description

About Karius

Karius is a life science, venture-backed clinical metagenomics company, focused on elevating patient care through microbial insights. We are committed to advancing diagnostic science and technology to optimize the diagnosis and treatment of infectious diseases. Through the use of genomics and AI, we are driven to improve the diagnostic landscape for infectious diseases. Karius delivers unprecedented diagnostic insight detecting microbial cell-free DNA circulating in the body to assist physicians to make rapid treatment decisions.

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, 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.

This is a part-time role with an expected schedule of approximately 28 hours per week. Specific workdays and hours will be determined based on business needs.

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 products Karius offers today are some of the most advanced solutions available to physicians who aim to deliver better care to many otherwise ineffectively treated patients. Our tests are 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: Director, Quality Assurance

Location: Redwood City, CA (this an hourly, non-exempt position)

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).

What’s Fun About the Job?

Karius is operating at the edge of what is now known to be possible in 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

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 manner.

Flexible, adaptive and comfortable in a rapidly evolving Biotech start-up environment.

1-2 years of pertinent industry experience is 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.

Knowledge of QMS standards.

Strong analytical and problem-solving skills.

Excellent attention to detail and organizational skills.