Laboratory Program Manager

Overview

Manages and supports Reference Laboratory programs and systems, with a primary focus on information systems, validation, implementation, and process improvement. Provides technical expertise to ensure system functionality and workflows support laboratory operational, quality, and regulatory requirements.

Responsibilities

The list of essential functions, as outlined herein, is intended to be representative of the duties and responsibilities performed within this classification. It is not necessarily descriptive of any one position in the class. The omission of an essential function does not preclude management from assigning duties not listed herein if such functions are a logical assignment to the position.

• Provides program management, technical expertise, and ongoing support for Laboratory and Reference Laboratory systems, including development, implementation, optimization, maintenance, and enhancement of laboratory programs and workflows
• Manages laboratory software initiatives, system enhancements, interfaces, and workflow improvement projects by coordinating requirements, risk and impact assessments, testing, validation, issue resolution, implementation readiness, and post-implementation support
• Plans, develops, executes, and documents acceptance testing, validation activities, test cases, and related documentation to ensure system functionality meets laboratory, operational, quality, and regulatory requirements
• Develops, and revises Standard Operating Procedures, controlled documentation, and validation records to support approved system, process, and workflow changes
• Coordinates training, implementation activities, and end-user support for new or revised laboratory systems, workflows, and processes
• Provides technical and operational support for Blood Establishment Computer System (BECS) and Laboratory Information System (LIS) functionality, including Reference Laboratory patient and donor testing, product modification, labeling processes, and related workflows
• Collaborates with Laboratory leadership, Information Technology, Quality, vendors, users, and other stakeholders, serving as the primary liaison and subject matter expert for laboratory systems and project-related activities
• Identifies and supports process improvements, standardization efforts, operational efficiencies, and quality initiatives while ensuring compliance with applicable regulatory and accreditation requirements
• Coordinates project plans, deliverables, documentation, status reporting, metrics, dependencies, and implementation activities to support successful program execution and ongoing performance monitoring
• Represents Laboratory management by providing leadership, technical guidance, and subject matter expertise for assigned programs and initiatives, including travel as needed to support implementation, validation, training, and operational needs
• Coordinates onboarding for new laboratory clients, monitors blood utilization programs, and supports utilization reviews to promote effective laboratory services and appropriate blood product utilization.

Qualifications

To perform this job successfully, an individual must be able to perform each essential duty and responsibility satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required.

EDUCATION AND/OR EXPERIENCE:

Bachelor’s degree in Medical Technology, Clinical Laboratory Science, Medical Laboratory Science, or related field, with five (5) years of relevant clinical laboratory experience; or an equivalent combination of education, training and/or experience. Experience with LIS, validation, implementation, training, and project coordination preferred.

CERTIFICATES, LICENSES, REGISTRATIONS AND DESIGNATIONS:

In Florida, a valid and current Florida Clinical Laboratory Technologist license in Immunohematology and/or Blood banking. If working in a state without laboratory personnel licensure requirements, must meet current CLIA requirements for high-complexity testing. Medical Technologist/Medical Laboratory Scientist certification from a nationally recognized certifying agency.

KNOWLEDGE, SKILLS AND ABILITIES:

• Advanced knowledge of blood banking, immunohematology, Reference Laboratory operations, and laboratory information systems.
• Proficient in Microsoft Suite applications and knowledge of laboratory quality systems, validation, change implementation as well as risk and impact assessments.
• Ability to translate laboratory requirements into system functionality, workflows, test cases, and acceptance testing activities.
• Ability to analyze complex workflows, identify risks and gaps, and develop practical solutions and standardized processes.
• Strong project management and organizational skills, with the ability to work independently, manage multiple priorities and meet established deadlines.
• Effective written and verbal communication, collaboration, documentation, training, and stakeholder coordination skills.
• Ability to establish and maintain effective and cooperative working relationships with those contacted in the course of work
• Ability to travel up to 40% and commute with personal transportation.

PHYSICAL REQUIREMENTS:

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.

Functions involve the ability to exert light physical effort in sedentary to light work, which may involve some lifting, carrying, pushing and/or pulling of objects and materials of light weight (up to 20 pounds).

ENVIRONMENTAL REQUIREMENTS:

The work environment characteristics described here are representative of those an employee may encounter while performing the essential functions of this job.

Functions are primarily performed inside with potential for exposure to pathogenic substances. Performance of this job could expose the employee to blood-borne pathogens. The noise level in the work environment is usually moderate.