Quality Assurance Specialist

Seneca Holdings • Atlanta, GA

8h • Onsite

About The Position

Great Hill Solutions, LLC is seeking a Quality Assurance Specialist to join their team in Atlanta, GA. The Quality Assurance Specialist will provide comprehensive laboratory quality assurance, quality management system (QMS), and safety program support for the Centers for Disease Control and Prevention's (CDC) Coronavirus and Other Respiratory Viruses Division (CORVD). This role is crucial for supporting laboratory quality initiatives by ensuring compliance with federal regulations, laboratory accreditation requirements, quality standards, biosafety requirements, and CDC policies. The QA specialist will assist with audit readiness, corrective action management, quality improvement initiatives, safety compliance monitoring, equipment management, risk assessments, and Quality Management System implementation across laboratory operations. The position serves as a key liaison between laboratory personnel, quality management staff, safety officers, and leadership to promote continuous quality improvement, operational excellence, and regulatory compliance.

Requirements

• Bachelor's degree in Medical Laboratory Science, Biology, Microbiology, Chemistry, Biochemistry, Life Sciences, or a related scientific field.
• Quality Management Systems (QMS)
• CAPA Management
• Risk Assessment & Mitigation
• Audit & Inspection Readiness
• CMS/CLIA Compliance
• Biosafety & Laboratory Safety Programs
• Equipment Lifecycle Management
• Temperature Monitoring Systems (e.g., MESA)
• SOP Development & Document Control
• Quality Metrics & Reporting
• Regulatory Compliance Management
• Must be a United States citizen or permanent resident or have authorization for employment in the United States to obtain and maintain the necessary security clearance for this role.

Nice To Haves

• Master's degree preferred.
• Certification as a Medical Technologist (MT), Medical Laboratory Scientist (MLS), Clinical Laboratory Scientist (CLS), or equivalent certification from an accredited professional certification board (e.g., ASCP, AMT, or AAB) is preferred.
• Experience working within CLIA, CMS, CAP, or ISO-regulated laboratory environments is highly desirable.

Responsibilities

• Support implementation, maintenance, and continuous improvement of Laboratory Quality Management Systems (QMS) to ensure compliance with CDC, CMS, CLIA, and applicable regulatory requirements.
• Conduct quality assessments, gap analyses, compliance reviews, and corrective action follow-up activities to identify and resolve quality management issues.
• Review, document, and monitor Non-Conforming Events (NCEs), deviations, corrective actions, preventive actions, and quality performance metrics.
• Coordinate laboratory audit readiness activities, including inspection preparation, compliance assessments, documentation reviews, and regulatory support.
• Manage laboratory temperature monitoring and environmental control programs, including review of alarm notifications, temperature excursions, trend analyses, and corrective actions.
• Maintain equipment inventories and support calibration, preventive maintenance, qualification, and replacement planning activities for laboratory systems and instrumentation.
• Support laboratory safety programs through safety compliance monitoring, training record management, hazard assessments, biosafety reviews, and incident investigations.
• Develop, revise, and maintain quality and safety Standard Operating Procedures (SOPs), policies, work instructions, and controlled documentation.
• Provide quality and safety training support, communicate quality initiatives to laboratory personnel, and participate in laboratory improvement and compliance working groups.
• Conduct risk assessments, identify quality and safety risks, recommend mitigation strategies, and support implementation of continuous quality improvement initiatives.

Benefits

• competitive pay
• benefits
• perks
• flexible work-life balance
• professional development opportunities
• performance and recognition programs
• comprehensive benefits package that includes medical, dental, vision, life, and disability
• voluntary benefit programs (critical illness, hospital, and accident)
• health savings and flexible spending accounts
• retirement 401K plan
• competitive health and welfare benefits
• paid leave programs

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level