Actively participates in outstanding customer service and accepts responsibility in maintaining relationships that are equally respectful to all. The Cellular Therapy Laboratory (CTL) Asst. Director is responsible for the administrative functions of the CTL, including quality, compliance and fiscal activities. The CTL Asst. Director represents the laboratory and the Progenitor Cell Transplant Program within AdventHealth through participation in activities at the national and international level. This position is responsible for ensuring that the Cellular Therapy Laboratory staff has the appropriate labor, supplies, equipment, facilities, training and support to conduct their designated duties within budget, efficiently, economically and safely in accordance with FH policies and procedures, and where applicable, to FL state and national licensure regulations and CAP (College of American Pathology) requirements. The position will also ensure that all staff adhere to the FH Corporate Compliance Plan, including HIPAA and confidentiality issues, to the rules and regulations of all applicable local state and federal agencies and to the standards of all accrediting bodies.
Knowledge, Skills, Education, & Experience Required:
- Strong organization skills
- Excellent analytical and problem-solving skills
- Effective oral and written communication skills, with the ability to articulate complex information in understandable terms to all levels of staff
- Effective computer skills, particularly Microsoft Office Outlook, Word, Excel
- Ability to work in a matrix-management environment to achieve organizational goals
- Working knowledge of Microsoft PowerPoint (Preferred)
- Bachelor's degree in Clinical Laboratory Science, Healthcare Administration or related field
- Master's degree in Clinical Laboratory Science, Healthcare Administration or related field (Preferred)
- Bachelor's degree in a clinical laboratory science
- At least ten (10) years experience with five (5) years of those being in the specific laboratory specialty, in both a licensed clinical laboratory and basic research laboratory setting
- Minimum three years of experience in a supervisory role
Licensure, Certification, or Registration Required:
- Active Valid State of Florida Medical Technologist License at the Supervisor level at Supervisor level in the appropriate clinical laboratory area (Chemistry, Immunology, and Immunohematology, Hematology, Immunology/Serology, Molecular and Chemical Chemistry)
- Medical Technologist (MT-ASCP) certification by the American Society of Clinical Pathology
Demonstrates through behavior AdventHealth's Core Values of Keep Me Safe, Love Me, Make it Easy, and Own it as outlined in the organization's Performance Excellence Program.
- Demonstrates, through behavior, AdventHealth 's core values of Integrity, Compassion, Balance, Excellence, Stewardship, and Teamwork
- The Asst. Director contributes to the continuous improvement of all issues related to compliance by adhering to all AdventHealth , State of Florida, and federal clinical laboratory rules, regulations and guidelines. He/she ensures that staff under his/her direct supervision are fully compliant with such regulations and that all licensed staff are fully conversant and compliant with clinical laboratory regulations. Ensures compliance with all regulatory and accrediting agency requirements for the CTL (i.e., DNV, FACT, ODH, AABB, CAP, FDA).
- The Asst. Director directs all technical and quality activities of the CTL. Develops implements and monitors all CTL processes, policies and procedures. Reviews all policies and procedures annually to ensure current and adequate. Develops and maintains an adequate quality assurance plan. Responsible for CTL Quality Management.
- Oversees all staff in the CTL, ensuring staff are appropriately trained and competent. Reviews and approves job descriptions. Interviews, hires and evaluates staff. Performs evaluations of direct reports and reviews performance. Initiates disciplinary actions where appropriate.
- Serves as a subject matter expert on aseptic techniques and cell therapy practices and procedures, current Good Tissue Practices (cGTPs), current Good Manufacturing Practices (cGMPS) for the Progenitor Cell Transplant Program, as well as members of the AdventHealth and other institutions.
- Compiles and analyzes data related to cell collection, processing, and storage, including appropriate outcome measures. Provides data to customers as required and appropriate. Reviews and approves all CTL projects, including equipment and supply qualifications, process validations, and quality control/assurance/improvement.
- Establishes and maintains systems and procedures to monitor the performance of the CTL.
- Assists with identification of improvement opportunities and strategies for the CTL, implementation and documentation of any corrective/ preventative action taken and evaluating effectiveness of such actions.
- Serves as a liaison with other AdventHealth departments to ensure the quality of CTL products and services. Assumes responsibility for investigation, problem-solving and decision-making between the CTL and other AdventHealth areas.
- Prepares operating budget for the CTL and monitors performance of salaries and benefits, purchasing and repair processes to ensure that laboratory meets budget goals and targets. Communicates financial goals and targets to staff. Determines capital needs for the CTL and prepares capital budget justification. Reviews and approves supply and equipment expenditures and ensures appropriate cost accounting and inventory control.
- Serves as co-chair of the Transplant Program Clinical Quality Management. Provides an annual update to the Transplant Program Clinical Quality management. As requested by the Transplant Program Medical Asst. Director, represents the Transplant Program and Laboratory on hospital committees and external assignments that affect operations of the department and the hospital. Participates on external scientific and professional committees in cellular therapy to advance the reputation of the Transplant Program and AdventHealth and as required for participation in cooperative clinical studies.
- Performs scheduled and unscheduled quality assessments, analyzes outcome and process indicators, generates quality assurance/ improvement reports, reviews with appropriate management, and makes recommendations based on results. Performs a comprehensive quality audit annually and reports to appropriate management on the overall performance of the quality system/ program.
- In conjunction with the Progenitor Cell Transplant Program/Laboratory Medical Asst. Director, establishes and defines goals, objectives and an operational plan that support the goals and objectives of the Transplant Program and AdventHealth .
- Implements and evaluates programs designed to achieve Laboratory goals and objectives. Collects, analyzes, and interprets statistical data to assist in planning and evaluation.
- Enhances the reputation of the Transplant Program and AdventHealth by presenting Laboratory processes, systems, and data at scientific meetings.