Quality Assurance Associate

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 companys 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).

Whats 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 dont 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.

Disclaimer

The above job description is intended to describe the general nature and level of work being performed by individuals assigned to this position. It is not intended to be an exhaustive list of all duties responsibilities and skills required. Responsibilities and duties may change or be adjusted to meet the needs of the company and additional duties may be assigned as necessary. The job description is subject to change at any time at the discretion of Karius.

At Karius we value a diverse and inclusive workplace and provide equal employment opportunities 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 individuals 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 emailprotected and we will accommodate qualified individuals with disabilities.