2 дня назад
Quality Assurance Specialist (Laboratory Quality)
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Quality Assurance Specialist (Laboratory Quality): Supporting laboratory quality management systems, regulatory compliance, audit readiness, safety programs, and equipment oversight for CDC respiratory virus operations with an accent on QMS implementation, CAPA management, biosafety, and inspection preparation. Focus on conducting risk assessments, managing corrective actions, monitoring environmental controls, and maintaining controlled laboratory documentation.
Location: Atlanta, GA, United States
Company
Federal government contracting business supporting civilian, defense, and intelligence community customers through mission-critical services.
What you will do
- Implement, maintain, and continuously improve laboratory Quality Management Systems in compliance with CDC, CMS, CLIA, and applicable regulatory requirements.
- Conduct quality assessments, gap analyses, compliance reviews, risk assessments, and corrective action follow-up.
- Coordinate audit and inspection readiness, including documentation reviews, compliance assessments, and regulatory support.
- Manage non-conforming events, deviations, CAPA activities, quality metrics, temperature monitoring, and environmental control programs.
- Maintain laboratory equipment inventories and support calibration, preventive maintenance, qualification, and replacement planning.
- Support biosafety and laboratory safety programs, SOP development, training, incident investigations, and continuous improvement initiatives.
Requirements
- Bachelor’s degree in Medical Laboratory Science, Biology, Microbiology, Chemistry, Biochemistry, Life Sciences, or a related scientific field.
- Experience with Quality Management Systems, CAPA management, risk assessment, audit readiness, regulatory compliance, and quality reporting.
- Knowledge of biosafety, laboratory safety programs, equipment lifecycle management, temperature monitoring, SOP development, and document control.
- Experience in CLIA, CMS, CAP, or ISO-regulated laboratory environments is highly desirable.
- Must be a United States citizen, permanent resident, or otherwise authorized to work in the United States to obtain and maintain the required security clearance.
Nice to have
- Master’s degree in a relevant scientific field.
- Medical Technologist, Medical Laboratory Scientist, Clinical Laboratory Scientist, ASCP, AMT, AAB, or equivalent certification.
Culture & Benefits
- Collaborative work environment focused on quality, operational excellence, and continuous improvement.
- Medical, dental, vision, life, and disability coverage.
- Health savings and flexible spending accounts, voluntary benefits, and a 401(k) retirement plan.
- Paid leave, flexible work-life balance, professional development, and performance recognition programs for eligible full-time employees.
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