Quality Assurance Associate — Biotech Documentation

Kariusdx; Redwood City (CA); On-site; USD 39,000 - 50,000; Part time

Job summary

Karius is seeking a part-time Quality Assurance Associate in Redwood City, CA to support the internal quality framework, audits, CAPAs, deviations, and training. This role requires strong writing, organization, and collaboration across teams in a rapidly evolving biotech startup.

The position is hourly, non-exempt, with ~28 hours per week. Reports to the Director, Quality Assurance, and involves managing controlled documents, SOPs, and training materials to ensure inspection readiness.

Qualifications

• 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.

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 and tracking of training, competency, and continuing education status.
• Ensures that documentation of training and competency records are prepared for review.
• Maintains SOPs, work instructions and quality records for quality assurance systems.
• Review and improve existing quality procedure workflows, and identify areas of improvement for efficiency and compliance.
• Administers training materials and modules for GLP activities.
• Support internal and external 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.
• Provides administrative support of incident management system.
• Supports documentation needs of Karius core teams.

Skills

QA documentation

GxP knowledge

Organizational skills

Attention to detail

Written communication

Education

BS in a biological science

Tools

Microsoft Office

Job description

Karius is seeking a part-time Quality Assurance Associate in Redwood City, CA to support the internal quality framework, audits, CAPAs, deviations, and training. This role requires strong writing, organization, and collaboration across teams in a rapidly evolving biotech startup.

The position is hourly, non-exempt, with ~28 hours per week. Reports to the Director, Quality Assurance, and involves managing controlled documents, SOPs, and training materials to ensure inspection readiness.