3 дня назад
Quality Assurance Associate
19 - 32$
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
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
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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