International Lab QA/QC Coordinator

The Pathology Department is seeking an International Lab QA/QC Coordinator who will work for Johns Hopkins University in support of the National Institutes of Health (NIH)-Division of AIDS research contract, SMILE (Patient Safety Monitoring in International Laboratories), and other sponsors in any future awards. Coordinator will manage a varied caseload and work with other International QA/QC Coordinators to provide support and assistance to sponsor funded international laboratories performing research and other clients as defined by our sponsor. Position is based at JHU in Baltimore. Limited International travel is required.

Specific Duties & Responsibilities

• Coordinate and monitor external quality assurance (EQA) activities.
• Compile data into statistical summary reports using Microsoft Excel or database program and provide status reports to the laboratory, NIH, and other study sponsors.
• Identify QA system failures, recommend solutions, and provide assistance to international laboratories when corrective actions are indicated. Review SOPs, reports, scientific protocols, and other papers as required.
• Provide status updates and/or recommendations to the NIH and other sponsors.
• Apply professional knowledge of medical technology principles, theories, practices, and methodologies to review, revise, maintain, and/or recommend quality improvement (QI), assurance (QA) & control (QC) programs in international laboratories.
• Work with the NIH and other study sponsors to provide materials and methods to ensure patient safety is monitored through appropriate QA systems.
• Review international laboratory assessment reports, create corrective action plans and provide technical assistance in resolving deficiencies.
• Will be required to research and select appropriate regulatory and scientific resource material which will be used to support/enhance suggested actions.
• Using Microsoft Excel or a database program, track progress and provide status reports to the SMILE manager, the laboratory, NIH and other study sponsors.
• Use knowledge of current accrediting and regulatory requirements to ensure international laboratories are in compliance with such requirements.
• Share knowledge gained from professional experience in the clinical laboratory to assure international laboratory compliance with current Good Clinical Laboratory Practice (GCLP) and other regulations and/or guidelines as defined by the NIH and other sponsors.
• Assist with website and website resource development. Utilize computer informatics for email communication, developing spreadsheets, databases, documents and presentations in order to technically assist international laboratories in meeting objectives defined by this project, the NIH and other sponsors.
• Attend meetings, conferences, and training sessions as directed by the SMILE manager.
• Update job knowledge by participating in educational opportunities; reading professional publications; maintaining personal networks; participating in professional organizations.
• Travel to client laboratories to remediate EQA, audit items and support Good Clinical Laboratory Practices (GCLP) sharing knowledge and expertise by providing training sessions, assistance and support to colleagues both internal and external. Able to develop and give educational presentations at conferences and during laboratory visits. International travel is required.

Special Knowledge, Skills, & Abilities

• Must be able to work independently and collaboratively in a team environment.
• Requires strong written and verbal communication skills.
• Manage time effectively while maintaining various project responsibilities.

Specific Physical Requirements

• While performing the duties of this job, the employee may remain in a stationary position (sitting) up to 60% of the time and standing/walking at 40%.
• Occasionally required to traverse throughout the laboratory or to retrieve equipment, supplies, or specimens from other locations on campus.
• The employee is required to operate computer keyboard, laboratory instruments, and small laboratory tools such as pipettes, cutting instruments, glass tubes, dishes, and/or slides. Constantly repositions self to perform duties at laboratory workstations, gathering specimens, and loading equipment.
• The employee is required to use hands/fingers to touch, type and/or feel.
• Will operate computer keyboard, and/or laboratory instruments, small laboratory tools such as pipettes, cutting instruments, glass tubes, dishes, and/or slides.
• Prolonged vision requirements including viewing computer screen, paper reports/documents charts and results. Visual acuity is required to distinguish fine gradation of color or structure and closely examine specimens (including via a microscope) for laboratory positions.
• Position is primarily in a laboratory environment where exposure to toxins and infectious agents exist, but potential for personal injury or harm is minimized if established safety and health precautions are followed for assigned work areas.
• Must refer to and are expected to comply with procedure manuals, follow proper laboratory protocols and safety policy/procedures, and be familiar with material data safety sheets in assigned work areas.
• Able to read and understand all Health, Safety and Environment (HSE) guidelines applicable to assigned work area.
• Working in laboratory where there may be discomforts due to odors, noise, temperature fluctuations, and working around lab equipment.
• Research areas may include animal, human, human products, DNA, and radiation protocols.
• Clinical Research and patient care duties may require direct interaction with patients at all levels of health or illness; including those noted with precautions/contagious symptoms or disease. Use of personal protective equipment may be advised or required.
• May transport equipment and supplies usually less than 40 pounds from one area to another including laboratory supplies or luggage. May be required to lift and/or move up to 50 pounds with proper training, or precautions/lifting aides. In some areas, workspace is limited.
• While most of our positions require on-site presence; where positions are approved for alternate work locations (remote work) – specific expectations will be outlined and documented; and the safety of work environment, security of work information, and productivity measures are regularly reviewed with employees and subject to on-going approval by management.
• Staff should be aware of and report other remote work implications and requirements that may impact them or the organization.
• Staff may be required to complete annual competency review, and must insure compliance with Johns Hopkins Policy, Laboratory Policy & Procedure, Health, Safety & Environment regulations, and all applicable privacy & confidentiality laws/practices.
• Annual training and testing requirements.
• Some areas maintain 24/7 operations and may require rotating shifts, evening, overnight, weekend, or holiday schedules. Some areas require on-call duties.
• Where designated positions are clinical or required attendance.
• In the event of a declared emergency; including but not limited to weather events, major disasters, or community unrest/events – staff may be required to report to work and/or remain at work.

• Bachelor of Science in Medical Technology, chemical or biological sciences.
• Four years related clinical laboratory experience.
• Strong working knowledge of computer informatics, skilled in Microsoft Office Word, Excel, Windows operating system, file organization, and internet research. Working knowledge of FDA, CAP, CLIA regulations and CLSI procedure formats applicable to an accredited clinical lab.

• ASCP (or equivalent) Medical Technologist certification preferred.

Classified Title: International Lab QA/QC Coordinator 
Role/Level/Range: ACRP/04/MD  
Starting Salary Range: $55,200 - $96,600 Annually ($65,000 targeted; Commensurate with experience) 
Employee group: Full Time 
Schedule: M-F, 7:00am-3:30pm 
Exempt Status: Exempt 
Location: Remote 
Department name: SOM Pat Clinical Chemistry 
Personnel area: School of Medicine