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3 дня назад

Quality Assurance Associate

19 - 32$
Формат работы
onsite
Тип работы
fulltime
Грейд
junior
Английский
b2
Страна
US
Вакансия из списка Hirify.GlobalВакансия из Hirify Global, списка международных tech-компаний
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Описание вакансии

Текст:
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TL;DR
Quality Assurance Associate (Clinical Laboratory Compliance): Documenting and tracking quality records for a clinical molecular laboratory with an accent on FDA QMSR, ISO 13485, CLIA, and CAP compliance. Focus on compiling device history records, maintaining audit-ready documentation, tracking deviations and corrective actions, and supporting supplier compliance workflows.

Location: Chicago, United States; Sunday–Thursday or Tuesday–Saturday shift.

Salary: $19.47–$32.45 per hour in Illinois.

Company

hirify.global develops a precision medicine platform that connects real-world evidence and genomic data to support clinical decision-making.

What you will do

  • Compile Device History Records and maintain quality documentation.
  • Read and follow SOPs within the document control system.
  • File and track batch records, checklists, equipment binders, and other quality records.
  • Maintain documentation supporting CLIA, CAP, NYS-DOH, FDA, and other regulatory requirements.
  • Report significant deviations and system deficiencies to management and support corrective and preventive actions.
  • Pull records for internal and external audits and assist with document control and supplier compliance workflows.

Requirements

  • High school diploma required; a bachelor's degree in life science or engineering is preferred.
  • 0–2 years of industry, quality, clerical, or documentation-handling experience.
  • Strong organization, attention to detail, time management, and communication skills.
  • Ability to complete repetitive tasks accurately, learn quickly, and adapt to new processes.
  • Basic computer skills and experience with Microsoft Office or Google Suite.
  • Ability to work independently in a fast-moving, cross-functional environment.

Nice to have

  • Previous experience in a clinical laboratory regulated by CAP, CLIA, NYS, or FDA.
  • Beginner-level process creation and solution development skills.

Culture & Benefits

  • Work supports precision medicine and cancer genomics initiatives.
  • Full-time employment with benefits that may include medical coverage, incentive compensation, and restricted stock units.
  • Opportunity to work within a regulated clinical molecular laboratory environment.
  • Scheduled Sunday–Thursday or Tuesday–Saturday shift.

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