Quality Assurance Associate

About the role

Karius is a life science, venture-backed clinical metagenomics company focused on elevating patient care through microbial insights. We advance diagnostic science and technology to optimize the diagnosis and treatment of infectious diseases using genomics and AI, delivering unprecedented diagnostic insight by detecting microbial cell-free DNA to assist physicians in making rapid treatment decisions.

This Quality Assurance Associate role is part-time (approximately 28 hours per week) and supports the internal quality framework by developing documentation and processes for audits, CAPAs, deviations, and more. The position requires high individual responsibility and accountability in a fast-paced biotech startup environment.

Responsibilities

• Supports and administers the document control system, including revision and maintenance of lab documents to ensure compliance with CLIA regulations
• Ensures documents are current, properly stored, and accessible to relevant personnel
• Assists with personnel onboarding (controlled document system, personnel binders) and tracks training, competency, and continuing education status
• Maintains standard operating procedures (SOPs), work instructions, and quality records for QA systems
• Reviews and improves existing quality procedure workflows to enhance efficiency and compliance
• Administers training materials and modules for GLP activities
• Supports internal and external (regulatory) audits as required
• Helps maintain Karius quality records in a state of inspection readiness
• Supports continuous improvement initiatives, including quality procedure workflows and aspects of the quality management system
• Provides administrative support for the incident management system
• Supports documentation needs of core teams (routing validation packages, laboratory change control forms)

Requirements

• BS in a biological science or related field preferred
• Excellent organization skills to coordinate 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
• Proactive, clear, and open communication style
• Flexible and adaptive in a rapidly evolving biotech startup environment
• 1–2 years of pertinent industry experience preferred
• Experience with deviations, lab investigations, Out of Specification results, and CAPAs preferred
• Strong knowledge of Microsoft Office applications

Personal Qualifications

• Excellent written and verbal communication skills
• Proactive, consistent, clear, and honest communication style
• 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

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
• May be exposed to hazardous materials, blood specimens, and instruments
• Some lifting (up to 25 pounds) may be necessary

Pay

$41.47 – $62.21 per hour