Senior Quality Assurance Specialist (Biotech)

TL;DR

Senior Quality Assurance Specialist (Biotech): Managing critical quality event processes and facility operations for cfDNA testing with an accent on compliance, CAPAs, and product safety. Focus on leading regulatory inspections, optimizing quality systems, and ensuring strict adherence to state and federal regulations.

Location: Onsite in San Carlos, CA

Salary: $93,800 – $117,300 USD

Company

hirify.global is a global leader in cell-free DNA (cfDNA) testing, dedicated to oncology, women’s health, and organ health.

What you will do

• Lead and manage critical quality event processes, including complaints, nonconformances, CAPAs, and deviations.
• Oversee day-to-day operations of the storage facility, products, and vendors to ensure safety and compliance.
• Monitor facility and product storage systems, providing timely responses to alarm notifications.
• Host and lead state and federal inspectors during regulatory inspections.
• Collaborate with leadership to identify quality improvement opportunities and implement new processes or technologies.
• Support the maintenance of Quality Systems for Document Control, Internal Audit, and Complaint investigations.

Requirements

• Bachelor's degree in science, engineering, medical technology, or a relevant discipline.
• 5+ years of work experience in the Clinical Laboratory or Biotech industry preferred.
• Must be based in San Carlos, CA to manage physical facility operations and inspections.
• Completion of HIPAA/PHI privacy, security, and general compliance training within 30 days of hire.

Culture & Benefits

• Comprehensive health benefits including medical, dental, and vision plans.
• 401(k) plan with company match and long-term equity awards.
• Generous paid time off and company holidays.
• Wellness and work-life benefits, including free testing for employees and their immediate families.
• Pregnancy and baby bonding leave and commuter benefits.