The Department of Pathology is seeking an International Lab QA/QC Coordinator-IT Project Specialistto work for Johns Hopkins University (JHU) in support of the National Institutes of Health (NIH)-Division of AIDS research contract, SMILE (Patient Safety Monitoring in International Laboratories), and other sponsors.
Primary Duties and Responsibilities:
Key position 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. Assume lead responsibilities in the absence of the Project Manager for both internal and external issues. Provide direction in core functions of the SMILE Project. Demonstrate technical expertise through training and/or presentations for SMILE staff and other project collaborators. 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.
Assist with website and website resource development while assuming a key role for enhancements and improvements of website used in the daily workflow. 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.
Coordinate and monitor external quality assurance 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.
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, Clinical and other study sponsors. Use knowledge of current accrediting and regulatory requirements to ensure international laboratories are in compliance with such requirements. 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. 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.
Attend meetings, conferences, and training sessions as directed by the SMILE manager. 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. Limited international travel is required.
Actively participate on committees as required. Perform committee chair duties and lead on special projects as assigned. Assist in team building, mentoring of staff and conflict resolution.
Ensure safe working conditions for staff, while maintaining compliance with the expectations of the project sponsor.
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.
Perform other related duties as assigned.
Bachelor’s degree in Medical Technology, chemical or biological sciences. Four years technical experience in a clinical laboratory. Experience in quality control and assurance. Technical experience in Hematology, Chemistry, Immunology and/or Microbiology.
Bachelor’s degree in Information Technology, Computer Science, Healthcare Management.
4 years related experience in information technology, database and/or web development and maintenance.
Microsoft Access or equivalent database experience.
Additional Knowledge, Skills, and Abilities:
Understanding or exposure to healthcare or clinical laboratory environments (chemistry, hematology, immunology, microbiology.
Working knowledge of FDA, CAP, CLIA regulations and CLSI procedure formats applicable to an accredited clinical lab.
Demonstrated skills in HTML, Cold Fusion, SQL Server, and Java Script.
Advanced skills in computer informatics, skilled in Microsoft Office Word, Excel, Windows operating system, file organization, and internet research.
Able to work independently and provide leadership in a team environment.
Demonstrate effective verbal and written communication skills with Project sponsor, management, networks and other collaborators.
Manage time effectively while maintaining various project responsibilities.
Technical Qualifications or Specialized Certifications: ASCP (or equivalent) Medical Technologist certification preferred.
Equipment, Machine, or Tool Requirements: Experience and understanding in laboratory instrumentation and equipment including: assay methods, maintenance requirements and general operational trouble shooting. Computer, Copier, Telephone, Fax.
Work Environment while performing the duties of this job:
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 or environmental 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.
Classified Title:International Lab QA/QC Coordinator / IT Project Specialist Role/Level/Range: ACRP/04/MD Starting Salary Range: $52,495.00 - $72,210.00;Commensurate with experience Employee Group: Full Time Schedule: Monday - Friday, 7:00am - 3:30pm; Occasional International Travel. Some telecommuting after training period is complete. Exempt Status: Exempt Location: JH at 111 Market Place Department Name: Pathology, 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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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.
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