Medical Laboratory Quality Assurance Coordinator (Edison, NJ)

Company Description

Avantic Medical Laboratory is a full-service clinical laboratory dedicated to delivering high-quality diagnostic testing to physicians, nursing homes, adult day care facilities, pharmacies, and urgent medical care centers. Based on years of experience with various labs nationwide, Avantic offers personalized services tailored to clients' unique needs through state-of-the-art instruments and technology. Accredited by CLIA, CAP, and Medicare/Medicaid, the lab provides a wide array of in-house diagnostic tests as well as partnerships with reference labs for specialized testing. Reports are available through multiple platforms, including EMR, the Avantic website, and a secure network, ensuring fast and easy access. With a focus on exceptional customer service and patient care, Avantic employs highly qualified staff to provide reliable services and foster strong client relationships.

Role Description

The Quality Assurance (QA) Coordinator supports the laboratory Quality Management System and works directly under the supervision of the Director of Quality and Clinical Operations. The QA Coordinator assists in maintaining compliance with CLIA, CAP, HIPAA, state regulatory requirements, and laboratory quality standards. This position is responsible for quality monitoring activities, regulatory readiness, document control, proficiency testing oversight, quality indicator tracking, and continuous quality improvement initiatives while maintaining the ability to perform bench testing as needed.

Essential Responsibilities

• Assist in the implementation and maintenance of the laboratory Quality Management System (QMS).
• Support CAP accreditation, CLIA compliance, HIPAA compliance, and applicable state regulatory requirements.
• Review CAP checklists and assist with inspection readiness activities.
• Manage and maintain MediaLab compliance and document control systems.
• Assist with policy and procedure review, revision, and document management.
• Monitor quality indicators and quality improvement initiatives.
• Coordinate proficiency testing activities and follow-up investigations.
• Assist with occurrence management, nonconformances, corrective actions, and CAPA investigations.
• Participate in internal audits and quality assessments.
• Review quality control data and quality trends.
• Assist with reagent lot-to-lot verification, instrument comparability studies, and quality validations.
• Monitor competency assessments and staff training records.
• Support regulatory inspections and accreditation surveys.
• Maintain recall, safety notice, and quality records.
• Generate quality reports, metrics, and dashboards using Microsoft Excel and other software tools.
• Collaborate with laboratory supervisors and technical staff to ensure ongoing compliance.
• Perform bench testing and provide operational laboratory support as needed.

Qualifications

• Bachelor's degree in Medical Laboratory Science, Clinical Laboratory Science, Biology, Chemistry, or related scientific field (required).
• Minimum two (2) years of clinical laboratory experience (required).
• ASCP certification preferred (MLS, MT, MLT, or equivalent).
• Strong preference for candidates with Chemistry and/or Hematology laboratory experience.
• Previous CAP-accredited laboratory experience strongly preferred.
• Experience reviewing and interpreting CAP checklists required.
• Previous quality assurance, quality management, or regulatory compliance experience preferred.

Knowledge and Skills

• Working knowledge of CLIA, CAP, HIPAA, and laboratory regulatory requirements.
• Demonstrated experience reviewing CAP checklist requirements and supporting inspection readiness activities.
• Experience using MediaLab for document control, competency assessment, inspections, and compliance management preferred.
• Understanding of quality control principles, quality assurance, and quality management systems.
• Knowledge of Westgard Rules, Levey-Jennings charts, quality indicator monitoring, proficiency testing, and statistical quality control concepts.
• Experience reviewing quality control data, proficiency testing performance, and quality investigations.
• Strong analytical, investigative, and problem-solving skills.
• Excellent organizational and documentation skills.
• Advanced Microsoft Excel skills preferred, including data analysis, trending, and reporting.
• Proficiency with Microsoft Word, Outlook, and electronic document management systems.
• Strong computer and data management skills.
• Ability to work independently and manage multiple priorities.
• Strong written and verbal communication skills.

Additional Requirements

• Willingness and ability to perform bench testing when operationally required.
• Willingness and ability to travel to laboratory patient service centers, collection sites, and satellite locations to perform quality audits, regulatory compliance reviews, competency assessments, document control activities, and inspection readiness evaluations.
• Valid driver's license and reliable transportation required.
• Ability to participate in quality improvement, process improvement, and regulatory compliance initiatives.
• Commitment to patient safety, quality management, and continuous quality improvement.
• Ability to work collaboratively with laboratory leadership, supervisors, technical staff, and collection site personnel.

Ideal Candidate

The ideal candidate is an experienced Medical Laboratory Scientist with a strong Chemistry and/or Hematology background who has hands-on experience with CAP accreditation standards, MediaLab, quality systems, proficiency testing, quality control review, and regulatory compliance activities, and is interested in advancing into a laboratory quality and compliance leadership role.

Full-Time

On-site (Edison, NJ)

Competitive compensation based on experience