Quality Assurance Specialist

Seneca Holdings; Atlanta (GA); On-site; USD 75,000 - 110,000; Full time

Job summary

Great Hill Solutions, LLC seeks a Quality Assurance Specialist in Atlanta, GA to manage laboratory quality assurance, QMS, and safety programs for CDC CORVD initiatives. This role ensures compliance with CDC policies, promotes continuous quality improvement, and collaborates with lab personnel, safety officers, and leadership.

The position requires a Bachelor's in a related field, preferred MT/MLS/CLS certification, and prior experience in CLIA/CMS/CAP or ISO environments.

Qualifications

• Bachelor's degree in Medical Laboratory Science or related field.
• Master's degree preferred.
• Certification as MT, MLS, CLS, or equivalent preferred.
• Experience in CLIA, CMS, CAP, or ISO-regulated labs desirable.

Responsibilities

• Support implementation and improvement of Laboratory Quality Management Systems to ensure regulatory compliance.
• Conduct quality assessments, gap analyses, compliance reviews, and corrective actions.
• Review/non-conforming events, deviations, CAPA, and performance metrics.
• Coordinate audit readiness activities including inspections and documentation.
• Manage laboratory temperature monitoring and environmental control programs.
• Maintain equipment inventories and calibration/maintenance planning.
• Support laboratory safety programs and incident investigations.
• Develop and maintain SOPs, policies, and controlled docs.
• Provide quality and safety training, and participate in improvement groups.
• Perform risk assessments and mitigate quality and safety risks.

Skills

QMS

CAPA Management

Audit & Inspection Readiness

CMS/CLIA Compliance

Biosafety & Safety Programs

Equipment Lifecycle

Temperature Monitoring

SOP Development

Quality Metrics & Reporting

Regulatory Compliance

Security Clearance

Education

Bachelor's degree in Medical Laboratory Science or related field

Master's degree preferred

Certification as MT/MLS/CLS preferred

Experience in CLIA/CMS/CAP or ISO labs desirable

Job description

Great Hill Solutions, LLCis part of the Seneca Nation Group (SNG) portfolio of companies. SNGis Seneca Holdings' federal government contracting business that meets mission-critical needs of federal civilian, defense, and intelligence community customers. Our portfolio comprises multiple subsidiaries that participate in the Small Business Administration 8(a) program. To learn more about SNG, visitthe website and follow us onLinkedIn.

Our team of talented individuals is what makes us successful. To support our team, we provide a balanced mix of benefits and programs.Your total rewards package includes competitive pay, benefits, and perks, flexible work-life balance, professional development opportunities, and performance and recognition programs. We offer a 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, and retirement 401K plan. One of our fundamental principles is to offer competitive health and welfare benefits to our team members, providing coverage and care for you and your family. Full-time employees working at least 30 hours a week on a regular basis are eligible to participate in our benefits and paid leave programs. We pride ourselves on our collaborative work environment and culture, which embraces our mission of providing financial and non-financial benefits back to the members of the Seneca Nation.

Great Hill is seeking a Quality Assurance Specialist to join our team in Atlanta, GA. The Quality Assurance Specialist provides 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 supports laboratory quality initiatives by ensuring compliance with federal regulations, laboratory accreditation requirements, quality standards, biosafety requirements, and CDC policies. The QA specialist assists 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.

MAJOR DUTIES AND 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.

QUALIFICATIONS

Education and Experience:

• Bachelor's degree in Medical Laboratory Science, Biology, Microbiology, Chemistry, Biochemistry, Life Sciences, or a related scientific field.
• 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.

CORE COMPETENCIES (Required Skills):

• Quality Management Systems (QMS)
• CAPA Management
• 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.

Equal Opportunity Statement: Seneca Holdings provides equal employment opportunities to all employees and applicants without regard to race, color, religion, sex/gender, sexual orientation, national origin, age, disability, marital status, genetic information and/or predisposing genetic characteristics, victim of domestic violence status, veteran status, or other protected class status. This policy applies to all terms and conditions of employment, including, but not limited to, hiring, placement, promotion, termination, layoff, recall, transfer, leave of absence, compensation and training. The Company also prohibits retaliation against any employee who exercises his or her rights under applicable anti-discrimination laws. Notwithstanding the foregoing, the Company does give hiring preference to Seneca or Native individuals. Veterans with expertise in these areas are highly encouraged to apply.