The Immunogenetics Laboratory in the Pathology Department is seeking a Lab QA/QC Coordinator who under the supervision of the Laboratory Manager will be responsible for planning, coordinating and overseeing all of the functions within the scope of Quality Systems, including the Quality Control and Quality Improvement Programs, Quality audits, and obtaining and maintaining all accreditations to ensure that services are of the highest quality.

Specific Duties & Responsibilities

• Maintain laboratory licensure and accreditation (CLIA, ASHI, NYS) through periodic renewals, new applications, method submissions and managing the proficiency testing program.

• Serve as the liaison between the clinical laboratory and accrediting agencies.

• Administer and manage the document control system, incident reporting system and personnel documentation

• Review all laboratory procedures and validation documentation for compliance following regulation and guidance

• Assure proper qualification of laboratory personnel according to regulatory standards.

• Perform regular internal quality audits in all laboratory sections; follow up with recommendations, corrective, and preventive actions as needed.

• Identify procedural and systemic compliance risks and recommend continuous improvements that complements existing practices.

• Review and follow up on non-conformances, deviations until resolution. Initiate corrective and preventative actions to address system deficiencies and drive implementation of corrective action plans.

• Oversee and manage quality system related meetings, collect and trend key performance indicators.

• Interface and collaborate with laboratory personnel to educate, provide training, and ensure compliance in all aspects of the clinical process.

• Serve as the Laboratory Safety Officer.

Special Knowledge, Skills & Abilities

• Excellent communication, computer and writing skills.

• Work produced is subject to precise measure of quantity and quality. Attention to detail is critical to the successful performance of this job as it directly affects patient outcomes.

• Knowledge of good lab practices and academic medical center & research environments, general medical terminology. Regulatory standards.

• Ability to perform tasks on computer and assigned systems at appropriate level for the job. For example, use of MS Office, email, phones, handheld devices; Pathology, JHM, and Hospital data & patient systems.

• Ability to operate assigned equipment, troubleshoot and follow standard operating procedures.

• Maintains accurate, organized, detailed, clear & concise work documentation, records/logs, written communication. Maintains a clean and safe working environment.

Physical Requirements

• While performing the duties of this job, the employee may remain in a stationary position (sitting) up to 60% of the time and standing/walking at 40%. Occasionally required to traverse throughout the laboratory or to retrieve equipment, supplies, or specimens from other locations on campus. 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. Constantly repositions self to perform duties at laboratory workstations, gathering specimens, and loading equipment.

• The employee is required to use hands/fingers to touch, type and/or feel. Will operate computer keyboard, and/or laboratory instruments, 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) for laboratory positions.

• Position is primarily in a laboratory environment where exposure to toxins and infectious agents exist, but potential for personal injury or harm is minimized if established safety and health precautions are followed for assigned work areas. 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. Clinical Research and patient care duties may require direct interaction with patients at all levels of health or illness; including those noted with precautions/contagious symptoms or disease. 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, workspace is limited.

• While most of our positions require on-site presence; where positions are approved for alternate work locations (remote work) – specific expectations will be outlined and documented; and the safety of work environment, security of work information, and productivity measures are regularly reviewed with employees and subject to on-going approval by management. Staff should be aware of and report other remote work implications and requirements that may impact them or the organization.

• Staff may be required to complete annual competency review, and must ensure compliance with Johns Hopkins Policy, Laboratory Policy & Procedure, Health, Safety & Environment regulations, and all applicable privacy & confidentiality laws/practices. Annual training and testing requirements.

• Some areas maintain 24/7 operations and may require rotating shifts, evening, overnight, weekend, or holiday schedules. Some areas require on-call duties. Where designated positions are clinical or required attendance. In the event of a declared emergency, including but not limited to weather events, major disasters, or community unrest/events – staff may be required to report to work and/or remain at work.

Minimum Qualifications

• Bachelor's Degree in Medical Technology, Chemistry, Biology, or related science.

• Four years clinical laboratory or quality compliance experience.

Preferred Qualifications

• Post-graduate Degree in relevant area.

• Professional certification is preferred (e.g. CQA, Six Sigma, CQM).

Classified Title: International Lab QA/QC Coordinator

Job Posting Title (Working Title): Lab QA/QC Coordinator

Role/Level/Range: ACRP/04/MD

Starting Salary Range: $55,200 - $96,600 annually ($71,308 targeted; commensurate with experience)

Employee group: Full Time

Schedule: M-F 8:30-5:00

Exempt Status: Exempt

Location: School of Medicine - East Baltimore Campus

Department name: SOM Pat Transfusion Medicine

Personnel area: School of Medicine

Equal Opportunity Employer:

Johns Hopkins University is an equal opportunity employer and does not discriminate on the basis of race, color, gender, religion, age, sexual orientation, national or ethnic origin, disability, marital status, veteran status, or any other occupationally irrelevant criteria. The university promotes affirmative action for minorities, women, disabled persons, and veterans.