Quality Assurance Associate – Biotech (Hybrid)

Natera; Austin, San Carlos (TX, CA); Hybrid; USD 48,000 - 55,000; Full time

Job summary

Natera is seeking an Associate Quality Assurance Specialist to support daily quality operations in a hybrid setting, with offices in San Carlos, CA or Austin, TX. You will gain exposure to FDA, ISO13485, CLIA, and CAP regulations while assisting with CAPAs, deviations, audits, and training records.

The role emphasizes documentation review, metric tracking, and collaboration with IT for eQMS access, designed for candidates with Life Sciences backgrounds and 0–2 years of regulated experience.

Qualifications

• Associate’s degree or higher in Life Sciences or related field; equivalent experience accepted.
• 0–2 years of work experience in a biotech or regulated environment preferred.
• Strong computer skills and ability to learn and adapt to systems and process changes.

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 or higher in Life Sciences

Tools

eQMS

Job description

Natera is seeking an Associate Quality Assurance Specialist to support daily quality operations in a hybrid setting, with offices in San Carlos, CA or Austin, TX. You will gain exposure to FDA, ISO13485, CLIA, and CAP regulations while assisting with CAPAs, deviations, audits, and training records.

The role emphasizes documentation review, metric tracking, and collaboration with IT for eQMS access, designed for candidates with Life Sciences backgrounds and 0–2 years of regulated experience.