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QA Specialist

5 hours, 22 minutes ago
United States
Full-time
Junior
Manual QA Tester
Quality Assurance and Testing
HIPAA
Apply Now
Natera

Natera

Natera specializes in cell-free DNA testing, providing advanced genetic testing services for oncology, women's health, and organ health to help families diagnose and manage genetic diseases.

Pharmaceuticals
1K-5K
Founded 2004
View All Jobs 97

Description

  • Support day-to-day management and operations of the facility, products, and vendors.
  • Assist employees with release, structure, and change control of controlled documentation and training plans.
  • Create new documents and revise existing documents and training plans for multiple functional teams.
  • Manage release and control of updates to Quality System and product-supporting documentation while maintaining data security.
  • Operate the electronic document management system (EDMS) so users have access to the latest approved revisions.
  • Partner with users to review and approve documents and records and participate in Quality System meetings as needed.
  • Collect and trend quality metrics under direct supervision and provide administrative oversight of QMS processes, including document control, training, CAPAs, deviations, SCARs, complaints, and NCRs.
  • Support internal and external audits, including serving as a scribe or internal auditor.
  • Stay current on applicable FDA, ISO13485, CLIA, CAP, and related regulations and guidance.
  • Complete assigned duties while continuing professional development through independent learning, training, and mentoring.

Requirements

  • Associate's degree, certificate, B.A., B.S., or equivalent; work experience may be considered in lieu of education.
  • 2+ years of work experience in a clinical laboratory or biotech industry preferred, or a relevant combination of skills, education, and experience.
  • Must work with PHI on a regular basis in both paper and electronic form.
  • Must complete HIPAA/PHI privacy, General Policies and Procedure Compliance, and security training within the first 30 days of hire.
  • Must maintain current Natera training requirements.
  • Must pass a post-offer criminal background check.
  • Ability to manage controlled documentation, training plans, and QMS processes in a regulated environment.
  • Familiarity with FDA, ISO13485, CLIA, and CAP requirements is preferred.
  • Experience with audits, document control, CAPAs, deviations, complaints, SCARs, or NCRs is preferred.

Benefits

  • Remote USA role with a salary range of $79,700 to $99,600 USD.
  • Comprehensive medical, dental, vision, life, and disability coverage for eligible employees and dependents.
  • Free testing for employees and their immediate families.
  • Fertility care benefits.
  • Pregnancy and baby bonding leave.
  • 401(k) benefits.
  • Commuter benefits.
  • Generous employee referral program.

Interested in this position?

Apply directly on the company website

Apply Now

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