Quality Systems Specialist II - Lab Compliance & Audits

BioReference Health, LLC.; Elmwood Park (NJ); On-site; USD 81,000 - 92,000; Full time

Job summary

BioReference Laboratories is seeking a Quality Specialist to join the Quality Systems Department at our Elmwood Park, NJ headquarters. This non-remote role requires travel and focuses on planning, coordinating, and maintaining the Quality Control Program and regulatory compliance to ensure top-quality services.

The role involves conducting quality audits, validating methods, coordinating proficiency surveys, and ensuring adherence to CLIA and other regulations.

Qualifications

• Bachelor of Science in Medical Technology required.
• 4+ years in a CLIA laboratory as a Medical Technologist or related role.
• Medical Lab Technician with 8+ years in a CLIA lab considered.
• ASCP or other national certification preferred; ASQ a plus.

Responsibilities

• Provides technical and quality oversight of areas of responsibility.
• Investigates non-conforming events and CAPAs as needed.
• Performs on-site visits to remote laboratories at least annually.
• Maintains regulatory compliance through documentation and audits.
• Assists in validation studies and review of experiments prior to submission.
• Supports inspection readiness and process improvement activities.
• Reviews proficiency survey results and corrective actions.
• Performs other responsibilities as mandated by CLIA and regulations.
• Reviews regulatory inspection reports with appropriate personnel.

Skills

Quality oversight

Audits

CAPA

Regulatory

Travel 30%

Education

Bachelor of Science in Medical Technology

ASCP certification preferred

ASQ certification a plus

Tools

ASQ Certification

Job description

BioReference Laboratories is seeking a Quality Specialist to join the Quality Systems Department at our Elmwood Park, NJ headquarters. This non-remote role requires travel and focuses on planning, coordinating, and maintaining the Quality Control Program and regulatory compliance to ensure top-quality services.

The role involves conducting quality audits, validating methods, coordinating proficiency surveys, and ensuring adherence to CLIA and other regulations.