The Department of Pathology 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. This role 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.
Minimum Qualifications (Mandatory):
Bachelor's Degree in Medical Technology 4 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.
Advanced knowledge of good laboratory practices required.
* Applicants who do not meet the posted requirements but are completing their final academic semester/quarter will be considered eligible for employment and may be asked to provide additional information confirming their academic completion date.
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.
Strong written and verbal communication, interpersonal, and training skills.
Coordinator will communicate with international laboratories, NIH and other sponsors in person, via email, and teleconference; therefore, cultural sensitivity in all areas of communication and appearance is required.
Technical Qualifications or Specialized Certifications:
ASCP (or equivalent) Medical Technologist certification preferred.
While performing the duties of this job, the employee may remain in a stationary position (sitting) up to 75% of the time when at the office.
Occasionally required to travel nationally and internationally (including developing countries), where working conditions will vary significantly including traversing on uneven terrain, working in extreme weather conditions, and taking appropriate caution for personal safety may be required.
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).
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.
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 work space is limited.
While this position is primarily in an office setting, there are times when you will work in a laboratory environment - Exposure to toxins and infectious agents exist, but potential for personal injury or harm is minimized if established safety and health precautions are followed.
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. Use of personal protective equipment may be advised or required.
Staff 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.
Classified Title: International Lab QA/QC Coordinator Role/Level/Range: ACRP/04/MD Starting Salary Range: $53,020 - $72,930 annually (commensurate with experience) Employee group: Full Time Schedule: M-F 7:00am - 3:30pm , occasional international travel. Some telecommuting after the training period is complete. Exempt Status: Exempt Location: Hybrid Department name: SOM Pat Clinical Chemistry Personnel area: School of Medicine
The successful candidate(s) for this position will be subject to a pre-employment background check.
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The pre-employment physical for positions in clinical areas, laboratories, working with research subjects, or involving community contact requires documentation of immune status against Rubella (German measles), Rubeola (Measles), Mumps, Varicella (chickenpox), Hepatitis B and documentation of having received the Tdap (Tetanus, diphtheria, pertussis) vaccination. This may include documentation of having two (2) MMR vaccines; two (2) Varicella vaccines; or antibody status to these diseases from laboratory testing. Blood tests for immunities to these diseases are ordinarily included in the pre-employment physical exam except for those employees who provide results of blood tests or immunization documentation from their own health care providers. Any vaccinations required for these diseases will be given at no cost in our Occupational Health office.
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