Laboratory Quality Coordinator – Regulatory Focus, 401k Matching

About the Company

Quest Diagnostics is the world’s leading provider of diagnostic information services. We provide insights that empower people to take action to improve health outcomes. Our diagnostic information services are relied upon by millions of patients and thousands of healthcare providers every day, enabling earlier detection of disease, selection of the best treatments, and monitoring of patient progress. We are committed to fostering a culture of quality, innovation, and excellence in all aspects of our operations.

Job Description

We are seeking a highly motivated and detail-oriented Laboratory Quality Coordinator with a strong regulatory focus to join our team in Downtown Newark, NJ. This pivotal role will be responsible for ensuring the laboratory’s quality management system adheres to all relevant federal, state, and local regulations, as well as industry standards. The ideal candidate will have a robust understanding of laboratory operations, quality assurance principles, and regulatory requirements (e.g., CLIA, CAP, FDA). You will play a crucial role in maintaining our accreditations, managing quality documentation, supporting audits, and driving continuous improvement initiatives within our cutting-edge laboratory environment. This position offers a unique opportunity to contribute to a company at the forefront of diagnostic innovation, with excellent benefits including 401k matching.

Key Responsibilities

• Develop, implement, and maintain the laboratory's Quality Management System (QMS) in compliance with CLIA, CAP, FDA, and other applicable regulatory standards.
• Coordinate and support internal and external audits (e.g., CAP, CLIA, FDA), ensuring readiness and timely resolution of findings.
• Manage and control quality documentation, including policies, procedures, forms, and records.
• Facilitate investigations into non-conformances, deviations, and complaints, driving root cause analysis and corrective/preventive actions (CAPA).
• Conduct regular quality audits and inspections to ensure adherence to established protocols and regulatory requirements.
• Provide training and guidance to laboratory staff on quality control procedures, regulatory compliance, and best practices.
• Monitor key quality indicators, analyze trends, and prepare reports for management review.
• Participate in continuous improvement initiatives aimed at enhancing laboratory efficiency, accuracy, and compliance.
• Stay current with changes in regulatory requirements and industry standards affecting laboratory operations.

Required Skills

• Bachelor's degree in Medical Technology, Clinical Laboratory Science, Biology, Chemistry, or a related scientific field.
• Minimum of 3-5 years of experience in a clinical laboratory setting with a focus on quality assurance and regulatory compliance.
• In-depth knowledge of CLIA, CAP, FDA, and other relevant laboratory regulations and accreditation standards.
• Proven experience in developing, implementing, and maintaining Quality Management Systems (QMS).
• Strong analytical, problem-solving, and organizational skills.
• Excellent written and verbal communication skills.
• Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint).

Preferred Qualifications

• Certification as a Medical Technologist (MT) or Clinical Laboratory Scientist (CLS) (ASCP or equivalent).
• Experience with LIMS (Laboratory Information Management System) and electronic document control systems.
• Prior experience in supporting successful regulatory inspections (e.g., FDA, CAP).
• Certifications in Quality Management (e.g., ASQ Certified Quality Auditor, Certified Quality Manager).

Perks & Benefits

• Competitive salary and comprehensive benefits package.
• 401k matching program.
• Medical, dental, and vision insurance.
• Paid time off and holidays.
• Professional development and continuing education opportunities.
• Employee assistance program.
• A collaborative and supportive work environment.

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