The Department of Pathology is seeking a Senior 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 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.
May be assigned responsibility for leading and organizing project teams and/or committees to achieve project or program goals.
In collaboration with the SMILE Manager assist with development of 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, to include planning and administration of international laboratory site visits. Demonstrate technical expertise through training and/or presentations for SMILE staff and other project collaborators.
Assist in team building, mentoring of staff and conflict resolution.
Act as a resource to staff for resolving difficult technical issues Assist in team building, mentoring of staff and conflict resolution.
Responsible for preparation of project deliverables in collaboration with the SMILE International QA/QC Manager for the contract sponsor.
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. May be assigned responsibility for leading and organizing project teams and/or committees to achieve project or program goals.
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 to include database design, protocol development and revision.
Research and select appropriate regulatory and scientific resource material which will be used to support/enhance the pSMILE website.
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.
Share knowledge and technical expertise by providing training sessions, assistance and support to colleagues both internal and external.
Minimum Qualifications (Mandatory):
Bachelor's Degree in Medical Technology, Chemical or Biological Sciences.
Minimum 10 years in clinical laboratory experience.
Technical experience in Hematology, Chemistry, Immunology and/or Microbiology.
Minimum two years experience working in the SMILE project.
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.
Experience as a lead technologist or QC/QA tech.
Special Knowledge, Skills & Abilities:
Must be able to work independently and provide leadership in a team environment.
Requires strong written and verbal communication skills with Project sponsor, management, networks and other collaborations.
Manage time effectively while maintaining various project responsibilities.
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.
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.
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).
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: Sr. International Lab QA/QC Coordinator Role/Level/Range: ACRP/04/ME Starting Salary Range: $61,550 - $84,700 annually (commensurate with experience) Employee group: Full Time Schedule: M-F 7:00am-3:30pm Exempt Status: Exempt Location: Hybrid Department name: SOM Pat Clinical Chemistry Personnel area: School of Medicine
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