Laboratory Program Manager

OneBlood•Orlando, FL

About The Position

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. The role provides program management and technical support for Laboratory and Reference Laboratory systems, coordinates software initiatives and workflow improvement projects, and plans and documents testing and validation activities. It also supports BECS and LIS functionality, controlled documentation, training, implementation, end-user support, client onboarding, and blood utilization programs. The position collaborates with Laboratory leadership, IT, Quality, vendors, users, and other stakeholders, and may require travel to support implementation, validation, training, and operational needs.

Requirements

Bachelor’s degree in Medical Technology, Clinical Laboratory Science, Medical Laboratory Science, or a related field, with five years of relevant clinical laboratory experience; or an equivalent combination of education, training, and/or experience.
In Florida, a valid and current Florida Clinical Laboratory Technologist license in Immunohematology and/or Blood Banking. In states 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.
Advanced knowledge of blood banking, immunohematology, Reference Laboratory operations, and laboratory information systems.
Proficiency in Microsoft Suite applications and knowledge of laboratory quality systems, validation, change implementation, and 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, including 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.
Ability to travel up to 40% and commute using personal transportation.
Ability to perform light physical effort in sedentary to light work, including some lifting, carrying, pushing, and/or pulling of objects and materials weighing up to 20 pounds.
Ability to work primarily indoors with potential exposure to pathogenic substances and blood-borne pathogens.

Nice To Haves

Experience with LIS, validation, implementation, training, and project coordination.

Responsibilities

Provide program management, technical expertise, and ongoing support for Laboratory and Reference Laboratory systems, including development, implementation, optimization, maintenance, and enhancement of programs and workflows.
Manage laboratory software initiatives, system enhancements, interfaces, and workflow improvement projects, including requirements coordination, risk and impact assessments, testing, validation, issue resolution, implementation readiness, and post-implementation support.
Plan, develop, execute, and document acceptance testing, validation activities, test cases, and related documentation to ensure system functionality meets laboratory, operational, quality, and regulatory requirements.
Develop and revise Standard Operating Procedures, controlled documentation, and validation records to support approved system, process, and workflow changes.
Coordinate training, implementation activities, and end-user support for new or revised laboratory systems, workflows, and processes.
Provide technical and operational support for BECS and LIS functionality, including Reference Laboratory patient and donor testing, product modification, labeling processes, and related workflows.
Collaborate 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.
Identify and support process improvements, standardization efforts, operational efficiencies, and quality initiatives while ensuring compliance with applicable regulatory and accreditation requirements.
Coordinate project plans, deliverables, documentation, status reporting, metrics, dependencies, and implementation activities to support program execution and ongoing performance monitoring.
Represent Laboratory management by providing leadership, technical guidance, and subject matter expertise for assigned programs and initiatives, including travel as needed.
Coordinate onboarding for new laboratory clients, monitor blood utilization programs, and support utilization reviews to promote effective laboratory services and appropriate blood product utilization.