Quality Assurance Associate

Job description

About this role

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. 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.

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.
• 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).

Qualifications and 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.
• Knowledge of QMS standards.
• Strong analytical and problem-solving skills.