Supervisor of Donor Testing Laboratory (Piedmont)

Monday-Friday 11:00pm-7:30am, one weekend a month required. 

Position Overview

The Supervisor of Donor Testing Laboratory provides day-to-day supervision and technical guidance to personnel performing donor infectious disease testing and related laboratory activities. This position supports the Manager of Donor Testing Laboratory in ensuring accurate and timely testing, regulatory compliance, staff training, quality control, and effective laboratory operations.

The Supervisor serves as a technical resource to laboratory staff and maintains a thorough working knowledge of donor testing procedures, equipment, laboratory information systems, and applicable regulatory and accreditation requirements. This is a working supervisory position that performs laboratory testing and other technical duties as needed while providing guidance, training, and oversight to staff. The Supervisor also assists with procedure development, validations, and other departmental initiatives.

Essential Functions

Laboratory Operations and Technical Oversight

• Provides day-to-day supervision, work direction, and technical guidance to Donor Testing Laboratory staff.
• Monitors laboratory workflow and workload to support timely and accurate completion of testing activities.
• Performs donor screening and other laboratory testing as needed and provides supervisory oversight of testing performed by laboratory staff.
• Performs and oversees automated cell counts on donor and patient samples and automated and manual cell counts on manufactured blood components, as applicable.
• Ensures required quality control procedures for reagents, equipment, and testing processes are completed accurately and in accordance with established procedures.
• Performs quality control activities as needed.
• Reviews laboratory testing and manufacturing records as required prior to the release of blood components for labeling.
• Provides supervisory review of laboratory results and quality control records.
• Identifies and assists in resolving testing, manufacturing, workflow, and other operational issues.
• Reports nonconformances and other quality concerns to Quality Assurance and appropriate laboratory leadership.

Staff Supervision, Training, and Competency

• Supervises Donor Testing Laboratory personnel and provides ongoing direction, support, and feedback.
• Evaluates employee performance based on job responsibilities, established performance expectations, and defined standards.
• Coaches, counsels, and administers corrective action in accordance with organizational policies and procedures.
• Assists with interviewing, selection, onboarding, and development of laboratory personnel, as applicable.
• Orients new employees to departmental operations, policies, procedures, and job-specific responsibilities.
• Assists in developing and maintaining training plans and educational materials addressing job responsibilities, technical procedures, quality requirements, safety, computer-based functions, and employee development.
• Trains and mentors staff to meet job-specific, organizational, regulatory, and accreditation requirements.
• Assesses initial competency during job-task training and ongoing competency at required intervals.
• Identifies performance or competency deficiencies and provides retraining as necessary.
• Ensures training and competency assessments are accurately documented and maintained in accordance with established requirements.

Quality and Regulatory Compliance

• Understands and supports the organization's quality goals and Quality Plan.
• Ensures departmental activities are performed in accordance with applicable policies, procedures, regulatory requirements, and accreditation standards.
• Assists in the development, implementation, and maintenance of policies, process descriptions, standard operating procedures, training plans, and validation protocols.
• Ensures appropriate processes are in place to identify and document events that may affect the safety, quality, or integrity of products and services.
• Conducts or assists with investigations of adverse occurrences and nonconformances involving Donor Testing Laboratory operations.
• Performs or participates in root cause analyses and assists with the development and implementation of appropriate corrective and preventive actions.
• Supports departmental readiness for regulatory inspections, accreditation surveys, and internal or external audits.

Donor, Product, and Client Testing Support

• Oversees processes related to donor testing and management of reactive or positive test results.
• Generates or oversees donor notification letters in accordance with established procedures.
• Coordinates or oversees shipment of donor samples to reference laboratories for confirmatory, supplemental, or other testing not performed internally.
• Performs and oversees quality control testing of blood products in accordance with established procedures, regulatory requirements, and applicable standards.
• Supports infectious disease client testing activities and provides technical assistance to client testing customers.
• Assists with the investigation and evaluation of customer complaints related to client testing.

Equipment, Systems, and Documentation

• Uses the laboratory information system and other organizational systems to manage donor testing information and support daily departmental operations.
• Ensures laboratory equipment is appropriately maintained, calibrated, and monitored in accordance with established procedures and manufacturer recommendations.
• Performs or oversees required equipment quality control, calibration, and maintenance activities.
• Assists in the development and implementation of validation protocols for laboratory equipment, processes, systems, and procedures.
• Ensures validation activities and results are appropriately documented.
• Ensures departmental procedures, forms, and records are maintained in accordance with organizational document control requirements.
• Ensures laboratory records are accurate, complete, and maintained in accordance with applicable procedures, regulatory requirements, accreditation standards, and record-retention requirements.
• Produces accurate, complete, and legible documentation.

Administration and Departmental Support

• Assists the Manager of Donor Testing Laboratory with the daily administration and operation of the department.
• Assists with departmental planning, staffing, workflow coordination, and other operational needs.
• Assists with developing and monitoring departmental budgets, as assigned.
• Supports departmental and organizational quality improvement initiatives.
• Maintains a clean, organized, and safe laboratory work environment.
• Maintains professional and effective working relationships with employees, leadership, internal departments, clients, vendors, and other stakeholders.
• Maintains confidentiality of sensitive employee, donor, patient, client, and organizational information.
• Performs other duties as assigned or required.

Minimum Qualifications

• Associate degree in Medical Laboratory Technology or bachelor's degree in Medical Technology, Medical Laboratory Science, Biological Science, or a related field required.
• MLT, MLS, MT, or other applicable laboratory certification through ASCP or another nationally recognized credentialing organization preferred, as applicable.
• Three to four years of progressively responsible experience in a donor testing, blood banking, transfusion service, clinical laboratory, or related laboratory environment strongly preferred.
• Experience working in an FDA-regulated, CLIA-certified, and/or AABB-accredited environment strongly preferred.
• Previous supervisory experience strongly preferred.
• Thorough knowledge of laboratory testing procedures, quality control principles, laboratory equipment, and applicable regulatory requirements.
• Valid Driver’s License with no major infractions and dependable transportation.
• Ability to communicate effectively, tactfully, and courteously to patrons, donors, sponsors and co-workers.
• Ability to organize and prioritize workload and meet deadlines.
• Excellent analytical, organizational, interpersonal, verbal, and written communications skills.
• Strong computer skills including intermediate skill level with Microsoft Word, Excel, and PowerPoint.
• Ability to work with all levels and in a diverse work environment. 
• Ability to establish and maintain effective working relationships with staff, management, and peers.
• Ability to exercise appropriate discretion when handling sensitive and confidential information.

Physical Demands

The physical demands described here are representative of those that must be met to successfully perform the essential functions of this job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Lifting to 25 pounds
• Sitting, standing or walking for an extended period
• Bending and twisting