International Lab QA/QC Coordinator

General Summary/Purpose

The International Lab QA/QC Coordinator 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. Will focus on internal controls and project management of IT assignment and resources. Development and maintenance of website and databases in the support of international lab quality projects. Individual demonstrates intermediate to advanced IT skills (i.e. HTML, Cold Fusion, SQL Server, JavaScript) and the necessary IT security and support of those systems. 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

• Lead for SMILE IT initiatives and projects; monitoring timelines and deliverables. Extensive IT project work including but not limited to: database design and programming of internal record keeping and control files. Provide internal control and management of assigned resources. Liaison for all IT projects that involve contractors and central IT support staff from the department or school. In collaboration with the SMILE Manager assist with development of IT project goals, objectives, policies and procedures.
• 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) and 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. Assist with website design and programming for improved functionality and usability for SMILE staff, NIH sponsor and external clients. Use expertise in mentoring staff on the use of those and other systems as developed. Act as a resource to staff for resolving difficult technical and IT issues. Responsible for preparation of project deliverables in collaboration with the SMILE International QA/QC Manager for the contract sponsor.
• 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

• Bachelor’s degree in Medical Technology, chemical or biological sciences. Four years technical experience in a clinical laboratory required. Technical experience in Hematology, Chemistry, Immunology and/or Microbiology required.
• Advanced skills in 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.

Preferred Qualifications

• Four years related experience in IT, database and/or web development and maintenance. Demonstrated skills in: HTML, Cold Fusion, PHP, SQL Server, Java Script, and Vue.js.

Special Knowledge, Skills, and Abilities

• 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.
• Committee membership, committee chair duties and lead on special projects as assigned.
• Aptitude and willingness to learn and apply new software development languages as needed.

(This is a not a Required Attendance position. In the event of unexpected university closings including inclement weather, the employee in this position is required to comply with the Johns Hopkins University and work group policies. The employee is responsible for ensuring safe working conditions for staff, while maintaining compliance with the expectations of the project sponsor.)

Technical Qualifications or Specialized Certifications:

• ASCP (or equivalent) Medical Technologist certification preferred.
• Computer, Copier, Telephone, Fax. Experience and understanding in laboratory instrumentation and equipment including: assay methods, maintenance requirements and general operational trouble shooting.

Work Environment / Physical requirements:

• 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.
• 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.
• 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.
• 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).
• 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.
• 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.
• Staff required to complete annual competency review, and must insure compliance with Johns Hopkins Policy, Laboratory Policy and Procedure, Health, Safety and Environment regulations, and all applicable privacy and confidentiality laws/practices.
  
  

Classified Title:International Lab QA/QC Coordinator
Working Title: International Lab QA/QC Coordinator ​​​​​
Role/Level/Range: ACRP/04/MD
Starting Salary Range:$52,495 - $72,210; Commensurate with experience
Employee group: Full Time
Schedule: Monday-Friday, 7:00am-3:30pm; Up to 37.5 hrs/ week
Exempt Status: Exempt
Location: 31-MD:JH at 111 Market Place
Department name: 10003048-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.

If you are interested in applying for employment with The Johns Hopkins University and require special assistance or accommodation during any part of the pre-employment process, please contact the HR Business Services Office atjhurecruitment@jhu.edu. For TTY users, call via Maryland Relay or dial 711.

The following additional provisions may apply depending on which campus you will work. Your recruiter will advise accordingly.

During the Influenza ("the flu") season, as a condition of employment, The Johns Hopkins Institutions require all employees who provide ongoing services to patients or work in patient care or clinical care areas to have an annual influenza vaccination or possess an approved medical or religious exception. Failure to meet this requirement may result in termination of employment.

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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