Hybrid QA Associate - Regulated Biotech Ops

Socket.dev; Austin (TX); On-site; USD 48,000 - 55,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

Life insurance

Disability insurance

401k

Commuter benefits

Employee referral program

Job summary

Natera is a global leader in cell-free DNA (cfDNA) testing, seeking an Associate Quality Assurance Specialist to support daily quality operations in a hybrid role based in Austin, TX or San Carlos, CA. You will assist with documentation review, audits, and training records.

Under supervision, you will gain exposure to FDA, ISO13485, CLIA, and CAP regulations while contributing to CAPAs, Deviations, SCARs, and NCRs, and coordinating with IT for eQMS access.

Qualifications

• Associate’s degree, certificate, or B.S./B.A. in Life Sciences or related field; equivalent experience accepted.
• 0–2 years of work experience in a biotech or regulated environment preferred.

Responsibilities

• Collect and trend quality metrics under supervision
• Provide administrative support for CAPAs, Deviations, SCARs, Complaints, and NCRs
• Support document review, qualification record tracking, and audit preparation
• Assist with scheduling and logistics for internal audits
• May serve as scribe or support during internal and external audits
• Help maintain training records and employee credential tracking
• Coordinate with IT for user access to eQMS and training systems
• Perform other duties as assigned

Skills

MS Office

Google Suite

Technical Writing

Communication

Education

Associate’s degree / B.S. in Life Sciences or related field

Job description

Natera is a global leader in cell-free DNA (cfDNA) testing, seeking an Associate Quality Assurance Specialist to support daily quality operations in a hybrid role based in Austin, TX or San Carlos, CA. You will assist with documentation review, audits, and training records.

Under supervision, you will gain exposure to FDA, ISO13485, CLIA, and CAP regulations while contributing to CAPAs, Deviations, SCARs, and NCRs, and coordinating with IT for eQMS access.