Sr. International Lab QA/QC Coordinator (Pathology)

Specific Duties & Responsibilities

• Compile data into statistical summary reports using Microsoft Excel or a database program and provide status reports to the laboratory, NIH, and other study sponsors.
• Identify QA system failures, recommend solutions, and assist 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 used to support/ enhance suggested actions. Using Microsoft Excel or a database program, track progress and provide status reports to the appropriate manager/director, the laboratory, NIH and other study sponsors.
• Use knowledge of current accrediting and regulatory requirements to ensure international laboratories comply with them.
• 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.

• Use computer informatics for email communication, developing spreadsheets, databases, documents, and presentations to technically assist international laboratories in meeting objectives defined by this project, the NIH and other sponsors.

• 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 as well as provide laboratory support for protocol related functions

• Able to develop and give educational presentations at conferences and during laboratory visits. (International travel is required).

• Assist with development of project goals, objectives, policies and procedures

• Assume lead responsibilities when necessary

• Assist in team building, mentoring of staff and conflict resolution.

• Other duties as assigned.

• Bachelor's Degree in Medical Technology, Chemical or Biological Sciences or related field.
• Six years of technical experience in a clinical laboratory. Technical experience in hematology, chemistry, immunology and/or microbiology.
• Medical Laboratory Scientist certification (ASCP) or equivalent.
• Additional education may substitute for required experience and additional related experience may substitute for required education beyond a high school diploma/graduation equivalent, to the extent permitted by the JHU equivalency formula.

Technical Skills & Expected Level of Proficiency

• Data Management and Analysis - Developing
• Digital Content Management - Developing
• International Travel and Cultural Competence - Developing
• Interpersonal Skills - Developing
• Operations Management - Developing
• Oral and Written Communications - Developing

Classified Title: Sr. International Lab QA/QC Coordinator
Job Posting Title (Working Title):Sr. International Lab QA/QC Coordinator (Pathology)
Role/Level/Range: ACRP/04/ME
Starting Salary Range: $64,600 - $113,300 Annually ($89,000 targeted; Commensurate w/exp.)
Employee group: Full Time
Schedule: Monday-Friday, 9:00am-5:00pm
FLSA Status:Exempt
Location: School of Medicine Campus
Department name: SOM Pat Pathology Medical Microbiology
Personnel area: School of Medicine