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Requisition ID:  116754

Lab QA/QC Coordinator

The Pathology Department is seeking a Lab QA/QC Coordinator who working under minimal supervision, this position will be responsible for 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 and Responsibilities

  • Maintain laboratory licensure and accreditation (CLIA, CAP, 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
  • Review, maintain and update standard operating procedures annually and as needed.
  • 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.
  • Assist with annual competency assessments.


Special Knowledge, Skills, and 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.


Specific Physical Requirements

  • While performing the duties of this job, the employee is regularly required to sit, talk, see and hear. May sit or stand for prolonged periods and occasionally required to walk. The employee is frequently required to use hands to finger, touch, feel, and type. May reach with hands and arms; stoop, kneel, or crouch. 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 microscopically. Must possess manual dexterity sufficient to work with small instruments and delicate equipment.
  • Clinical 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. Working in laboratory where there may be discomforts due to odors, noise, temperature fluctuations, and working around lab equipment.
  • May transport equipment and supplies usually less than 40 pounds from one area to another. 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 confined; therefore mobility may be difficult.
  • Staff may be required to complete annual competency review, and must ensure compliance with Hospital Policy, Laboratory Policy & Procedure, Health, Safety & Environment regulations, and all applicable privacy & confidentiality laws/practices.
  • Must be detail oriented, organized, and accurate.
  • Many department laboratories operate 24/7 with schedules on day, evening, or night shift. Rotating schedules which may include weekend work and holiday assignment. Overtime possible when authorized/needed to meet business and patient needs.
  • 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.


Minimum Qualifications
  • Bachelor's degree in medical technology or related science (Clinical Laboratory Science, Biology, Chemistry, etc.). 
  • 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: $55,800 - $97,600 Annually ($70,000 targeted; Commensurate with experience) 
Employee group: Full Time 
Schedule: Monday-Friday 8:30am-5:00pm 
Exempt Status: Exempt 
Location: School of Medicine Campus 
Department name: ​​​​​​​SOM Pat Molecular Diagnostics Lab  
Personnel area: School of Medicine 

 

 

Total Rewards
The referenced base salary range represents the low and high end of Johns Hopkins University’s salary range for this position. Not all candidates will be eligible for the upper end of the salary range. Exact salary will ultimately depend on multiple factors, which may include the successful candidate's geographic location, skills, work experience, market conditions, education/training and other qualifications. Johns Hopkins offers a total rewards package that supports our employees' health, life, career and retirement. More information can be found here: https://hr.jhu.edu/benefits-worklife/.

Education and Experience Equivalency
Please refer to the job description above to see which forms of equivalency are permitted for this position. If permitted, equivalencies will follow these guidelines: JHU Equivalency Formula: 30 undergraduate degree credits (semester hours) or 18 graduate degree credits may substitute for one year of experience. Additional related experience may substitute for required education on the same basis. For jobs where equivalency is permitted, up to two years of non-related college course work may be applied towards the total minimum education/experience required for the respective job.

Applicants Completing Studies
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.

Background Checks
The successful candidate(s) for this position will be subject to a pre-employment background check. Johns Hopkins is committed to hiring individuals with a justice-involved background, consistent with applicable policies and current practice. A prior criminal history does not automatically preclude candidates from employment at Johns Hopkins University. In accordance with applicable law, the university will review, on an individual basis, the date of a candidate's conviction, the nature of the conviction and how the conviction relates to an essential job-related qualification or function.

Diversity and Inclusion
The Johns Hopkins University values diversity, equity and inclusion and advances these through our key strategic framework, the JHU Roadmap on Diversity and Inclusion.

Equal Opportunity Employer
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

EEO is the Law
https://www.eeoc.gov/sites/default/files/2023-06/22-088_EEOC_KnowYourRights6.12ScreenRdr.pdf

Accommodation Information
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 Talent Acquisition Office at jhurecruitment@jhu.edu. For TTY users, call via Maryland Relay or dial 711. For more information about workplace accommodations or accessibility at Johns Hopkins University, please visit https://accessibility.jhu.edu/.

Vaccine Requirements
Johns Hopkins University strongly encourages, but no longer requires, at least one dose of the COVID-19 vaccine. The COVID-19 vaccine does not apply to positions located in the State of Florida. We still require all faculty, staff, and students to receive the seasonal flu vaccine. Exceptions to the COVID and flu vaccine requirements may be provided to individuals for religious beliefs or medical reasons. Requests for an exception must be submitted to the JHU vaccination registry. This change does not apply to the School of Medicine (SOM). SOM hires must be fully vaccinated with an FDA COVID-19 vaccination and provide proof of vaccination status. For additional information, applicants for SOM positions should visit https://www.hopkinsmedicine.org/coronavirus/covid-19-vaccine/ and all other JHU applicants should visit https://covidinfo.jhu.edu/health-safety/covid-vaccination-information/.

The following additional provisions may apply, depending upon campus. Your recruiter will advise accordingly.
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.
School of Medicine - East Baltimore Campus

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