Job Description

About us

Eccolab Group, Co. is a licensed, independent full-service clinical laboratory headquartered in Miami, Florida, with additional facilities in Tampa. Established in 2001, we provide comprehensive analytical services to a diverse clientele, including hospitals, skilled nursing facilities, assisted living centers, and research organizations. With a strong focus on accuracy, innovation, and client education, we are committed to improving patient outcomes through fast, reliable diagnostics and cutting-edge laboratory technologies. Our team upholds the highest standards in quality assurance, compliance, and customer service. Visit us at eccolabgroup.com for more information.

Job Summary

The Clinical Laboratory Quality Manager is responsible for ensuring that all laboratory processes, procedures, and documentation meet established quality standards and comply with regulatory requirements. This role plays a critical part in monitoring and maintaining the integrity of clinical operations by conducting audits, identifying areas of non-compliance, implementing corrective actions, and driving continuous improvement initiatives. The QA Specialist collaborates closely with laboratory personnel, supervisors, and management to uphold quality performance, ensure accurate reporting, and support accreditation standards. Attention to detail, analytical thinking, and a strong understanding of clinical laboratory protocols are essential to the success of this role.

Scope

The Clinical Laboratory Quality Manager operates as a central authority in enforcing and maintaining quality systems across all departments within the laboratory. This role has the authority to initiate quality-related investigations, halt processes that deviate from standard protocols, and recommend strategic changes to enhance operational excellence and compliance.

In addition to overseeing documentation control, internal audits, quality metrics, and proficiency testing programs, this lead will also be directly involved in supporting and operating the laboratory's advanced automation systems. The Clinical Laboratory Quality Manager is expected to have hands-on experience working with laboratory automation, particularly with Beckman instruments, and must be capable of validating, troubleshooting, and optimizing workflows using these systems.

This position serves as a vital link between regulatory standards and daily operations, ensuring full readiness for CAP, CLIA, COLA, and OSHA inspections. The ideal candidate will not only enforce quality standards but also play an instrumental role in integrating automated processes into the lab's quality management framework. Proficiency with Laboratory Information Systems (LIS) and the ability to interface automation platforms into broader QA procedures are essential to this role's success.

Essential Duties/Responsibilities

Develop, implement, and maintain the laboratory's Quality Management System (QMS) in alignment with COLA, CLIA, OSHA, and other applicable regulatory standards. Conduct internal quality audits, identify areas of non-compliance, and track corrective and preventive actions (CAPA) to resolution. Monitor and maintain documentation control procedures, ensuring accuracy, version control, and compliance with regulatory requirements. Review and approve standard operating procedures (SOPs) and ensure staff adherence through training and routine checks. Oversee proficiency testing processes, monitor performance data, and investigate discrepancies to ensure accurate and reliable testing outcomes. Lead root cause analyses for quality incidents or deviations and collaborating with department leads to implement corrective actions. Prepare and support regulatory inspections and accreditation surveys (e.g., COLA, CLIA), ensuring full readiness and documentation integrity. Maintain quality metrics dashboards and provide regular reports to leadership on compliance trends, risks, and improvement opportunities. Facilitate training on quality and compliance protocols for laboratory personnel to reinforce a culture of accountability and excellence. Serve as the primary liaison for quality assurance-related communication between internal departments and external regulatory bodies.

Qualification

Education:

Bachelor's degree in medical laboratory science, Biology, Chemistry, or a related scientific or healthcare field required. Advanced degree or certification in Quality Management is a plus.

Experience:

Minimum 2-4 years of experience in a clinical laboratory or healthcare QA/QC role, with demonstrated knowledge of quality systems, regulatory compliance, and audit preparation.

Regulatory Knowledge:

Strong understanding of CLIA, COLA, CAP, OSHA, and other relevant laboratory accreditation and regulatory standards.

Technical Skills:

Proficiency in Laboratory Information Systems (LIS), data analysis, document control platforms, and Microsoft Office Suite (especially Excel for tracking and metrics).

Analytical Thinking:

Ability to perform root cause analyses, interpret complex regulations, and recommend practical, compliant solutions.

Communication:

Strong written and verbal communication skills; capable of drafting SOPs, audit reports, and training documentation.

Attention to Detail:

High level of accuracy in documentation, reporting, and process monitoring.

Training & Leadership:

Experience facilitating staff training, leading audits, or participating in safety and quality committees is preferred.

Certifications

(preferred but not required)*: ASCP, CQA (Certified Quality Auditor), or other relevant laboratory or quality assurance certifications.

Skills/Abilities

Technical Skills:

Proficient in data entry software and database management systems, with a strong aptitude for quickly learning and adapting to new technologies.

Attention to Detail:

High level of accuracy in specimen handling, data entry, and documentation.

Organizational Skills:

Ability to manage multiple priorities while maintaining organization and meeting deadlines.

Communication Skills:

Strong verbal and written communication for accurate reporting and effective collaboration.

Regulatory Knowledge:

Understanding of applicable healthcare regulations, including HIPAA, OSHA, and DOH standards.

Health & Safety Awareness:

Commitment to maintaining a safe laboratory environment and adhering to safety protocols.

Problem-Solving:

Capable of identifying and resolving minor equipment and testing issues independently.

Adaptability:

Comfortable working under pressure in a

fast-paced

and evolving laboratory setting.

Team Collaboration:

Works well with others in a multidisciplinary setting; cooperative and dependable.

Confidentiality:

Strict adherence to patient privacy laws and ethical handling of sensitive data.

Bilingual Communication

- Fluent in both English and Spanish; able to communicate effectively with diverse teams and stakeholders.

Charismatic Leadership

- Motivated, approachable, and confident with a "lead by example" mindset that inspires team accountability.

Self-Starter

- Proactive and disciplined, able to take initiative and drive improvements without constant supervision.

Positive Attitude & Energy

- Brings high energy and optimism to the workplace, fostering a collaborative and solutions-focused environment.

Key Requirements

Authorized to work in the U.S. with valid I-9 documentation. Available for extended hours, weekends, or holidays as needed (If required) Subject to background check and drug screening per Florida law. Completion of HIPAA and OSHA training upon hire; ongoing compliance required. Adherence to HIPAA, FIPA, and all confidentiality regulations. Compliance with Florida Department of Health and CDC safety protocols. Professional appearance and conduct required in a clinical setting. Willing to perform additional duties as assigned.
Job Types: Full-time, Contract

Pay: From $70,000.00 per year

Benefits:

Dental insurance Health insurance Paid time off Vision insurance
Language:

English (Required)
Location:

Miami, FL 33144 (Required)
Shift availability:

Day Shift (Required)
Ability to Commute:

Miami, FL 33144 (Required)
Willingness to travel:

75% (Required)
Work Location: In person