Anatomic Pathology QA Technical Specialist

Responsibilities:

• Technical Services: Monitor pre-analytical, analytical and post analytical phases of test systems; Periodically reviews the range and types of tests offered to ensure laboratory services remains supportive of advances in clinical laboratory testing systems; Keeps abreast of technical development in area of specialization; acts as a resource person for the section’s services; maintains technical ability and knowledge required to supervise the performance of any procedure in the section; Assists in the formulation and monitoring of a Quality Control/Quality Improvement program; takes responsibility for staff errors; As assigned, oversees and resolves test system problems for all assays through instrument troubleshooting, assessing operator performance and monitoring trends in patient data and quality control data to determine proper instrument/method performance; As assigned, develops new assays through to validation; As assigned, ensure enrollment in appropriate Proficiency Testing programs which meet federal, state and accrediting agency requirements. Manages the entry of results into appropriate database for all proficiency testing results; Monitors workflow and workload within the sections adapts operational plan accordingly in a timely manner; Assists clinicians and researchers in utilizing lab services in support of special projects and research protocols. Meets with clinical research sponsors/auditors to review lab service support for various clinical trials; As assigned, ensures equipment is maintained with appropriate documentation; follows manufacturer’s guidelines and routine preventive maintenance schedules for all equipment in the sections; As required, assumes bench responsibilities when required; maintains competency in all technical aspects of the section; is able to perform, troubleshoot, and explain each test procedure currently performed in the section; Performs teaching functions with residents and Medical Laboratory Science Students.

• Regulatory Compliance: Works with the Division’s Quality Assurance manager in functioning as liaison to accrediting / regulatory agencies in preparation for inspections, site visits, documentation of compliance, deficiency corrections, status changes and licensing renewals; Maintains an updated database related to Federal, State and local government agencies and professional accrediting agencies’ regulatory requirements impacting lab operations including: AABB, CMS(Center for Medicare/Medicaid Services), DOH (Appropriate state Dept. of Health), DOH (Bureau of Laboratories), CAP (College of American Pathologists), CLSI (Clinical laboratory Standards Institute), FDA, FACT, TJC (The Joint Commission), OSHA (Occupational Safety and health Act), NRC (Nuclear Regulatory Commission), DEA (Drug Enforcement Agency), DOT (Dept. of Transportation: Shipment of Hazardous Material); Ensures that all quality control, instrument records, test records and other documentation are maintained in a manner which complies with all regulatory requirements; Ensures that review of department operating policies and processes are performed within required time limits; Monitors and participates in department efforts to maintain a safe working environment through development of safety policies, ongoing surveillance of environment and work practices. Ensures deficiencies noted are corrected.

• Performs duties in accordance with Penn Medicine and entity values, policies, and procedures

• Other duties as assigned to support the unit, department, entity, and health system organization

Credentials:

• MLS (ASCP) or other equivalent certification (Preferred)
• Additional education and or training in Management or Lab Management (Preferred)

Education/Experience:

• Bachelor's Degree (Required) in Medical Laboratory Science or other biological or chemical science or U.S. equivalent (substantiated by foreign credential evaluation statement)
• Possess the ability to perform tasks that require accurate and specific color distinction.
• 2+ years of Clinical lab experience (Preferred)
• 2+ years of experience managing high volume clinical labs while meeting superior customer satisfaction expectations (Preferred)
• Knowledge of and ability to manage the general hazards encountered when working with potentially infectious materials, hazardous chemicals, radioisotopes and laboratory equipment.