QA Specialist (Biotech)

TL;DR

QA Specialist (Biotech): Managing quality assurance operations for facilities, products, and vendors with an accent on regulatory compliance and documentation control. Focus on maintaining QMS processes, conducting internal audits, and ensuring adherence to FDA, ISO13485, CLIA, and CAP standards.

Location: Remote (USA)

Salary: $79,700 – $99,600 USD

Company

hirify.global is a global leader in cell-free DNA (cfDNA) testing focused on oncology, women's health, and organ health.

What you will do

• Manage and operate facility quality assurance, products, and vendors.
• Control the release, structure, and change of all controlled documentation and training plans.
• Oversee the Electronic Document Management System (EDMS) to ensure data security and version control.
• Collect and trend quality metrics while providing administrative oversight of QMS processes including CAPAs, deviations, SCARs, complaints, and NCRs.
• Stay current on FDA, ISO13485, CLIA, and CAP regulations.
• Support internal and external audits, potentially serving as an internal auditor.

Requirements

• Associate's Degree, B.A., B.S., or equivalent (relevant work experience may be considered).
• 2+ years of work experience in Clinical Laboratory or Biotech industry preferred.
• Must be based in the USA.
• Must pass a post-offer criminal background check.
• Must complete HIPAA/PHI privacy and security training within 30 days of hire.

Culture & Benefits

• Comprehensive medical, dental, vision, life, and disability plans for employees and dependents.
• 401k benefits and commuter benefits.
• Pregnancy and baby bonding leave.
• Free genetic testing for employees and immediate families, including fertility care benefits.
• Generous employee referral program.