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Quality Assurance Specialist – Atlanta, GA

UCI-OC Alliance · Couffo

🇬🇧 English
Quality Assurance Equipment validation Document control Temperature monitoring Sampling inspection

Job description

About the role

The U.S. Department of Health and Human Services is seeking a Quality Assurance Specialist to support the Strategic National Stockpile (SNS) program in Atlanta, GA. The role ensures that all pharmaceutical products handled by SNS meet cGMP standards and other regulatory requirements.

Key responsibilities

  • Conduct regular inspections of SNS facilities to verify cGMP compliance and document any deficiencies.
  • Review equipment validations, document control systems, temperature monitoring data, cold‑chain integrity, deviations, CAPAs, and preventive maintenance records.
  • Recommend and update testing criteria for temperature monitoring equipment, computerized systems, and cold‑storage units.
  • Participate in analysis, tracking, and trending of quality events to support cGMP Quality Systems.

Required profile

  • Undergraduate or graduate degree in quality assurance, statistics, engineering, computer science, physical sciences, or a related field.
  • Specialized experience demonstrating practical knowledge of monitoring, controlling, or maintaining product quality in inspection, production, or procurement environments.
  • U.S. citizenship is mandatory.

Required skills

  • Quality Assurance
  • Statistical analysis and data interpretation
  • Equipment validation
  • Document control
  • Temperature monitoring systems
  • CAPA (Corrective and Preventive Action) management
  • Sampling inspection techniques
  • Trend analysis of quality data

What we offer

  • Opportunity to work on critical national health security initiatives.
  • Professional development within a federal agency.

Questions fréquentes

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Published 2 months ago

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UCI-OC Alliance

Couffo