Laboratory Certification and Compliance Specialist (#MGBH01)
$59,055.00 Yearly Min / $78,740.00 Yearly Mid / $98,425.00 Yearly Max

Quality Assurance Laboratory Manager (#MGBH02)
$70,989.00 Yearly Min / $94,652.00 Yearly Mid / $118,315.00 Yearly Max

This class series uses two levels in the Agriculture, Natural Resources and Sciences occupational group, Sciences occupational series and describes work involving determining clinical laboratories' compliance with federal Health Care Financing Administration (HFCA) regulations as well as regulations of the Delaware State Board of Health.

Essential functions are fundamental, core functions common to all positions in the class series and are not intended to be an exhaustive list of all job duties for any one position in the class. Since class specifications are descriptive and not restrictive, incumbents can complete job duties of similar kind not specifically listed here.

• Determines compliance with federal and state laboratory regulations governing areas such as laboratory personnel qualifications, quality control, proficiency testing, laboratory management practices, laboratory analytical methods, and instrumentation, equipment and procedures used.
  
  
• Gathers and compiles data through audits, interviews and other sources; reviews, analyzes and evaluates records and reports.
  
  
• Investigates complaints concerning laboratory testing practices such as quality assurance deviations, and allegations of non-compliance or incorrect test results.
  
  
• Monitors laboratory responses and proficiency test results according to regulations and procedures to assure timely relevant reports are provided by all laboratories.
  
  
• Makes presentations and provides consultation to laboratory providers to enhance voluntary compliance with laboratory regulations.
  
  
• Writes reports identifying findings and deficiencies.

Laboratory Certification and Compliance Specialist

This is the first level of laboratory certification and compliance work.

• Reports to a technical superior.
• Performs the full range of essential functions.
• Conducts on-site surveys of laboratories to determine compliance with federal and state laboratory regulations.
• Conducts follow-up inspections of laboratory surveys to verify correction of deficiencies.
• Makes recommendations to superior for approval/disapproval of certification or licensure.
• Recommends to superior training needs for clinical laboratory provider staff.
• May serve as an expert witness in a court.

Quality Assurance Laboratory Manager

This level administers the Quality Assurance Program for Delaware Public Health Laboratory and associated Division of Public Health Field Laboratories and for performing administrative/supervisory work in the area of complex chemical/biological testing and analysis.

• Reports to an administrative superior.
• Supervision is exercised over at least two or more merit full time positions per Merit Rule 5.1460. The elements of supervision include planning, assigning, reviewing, evaluating, coaching, training, recommending hire/fire and discipline.
• Ensures laboratory activities/operations conform with applicable quality assurance policies, procedures, standards and regulatory requirements.
• Designs forms, tools, systems and methodologies for data collection and analysis.
• Reviews, monitors and recommends new and revised operational or administrative policies and procedures to maintain proper testing and analysis services and to reduce laboratory liability. Conducts special studies as necessary.
• Coordinates internal quality assurance activities of each analytical section.
• Organizes education programs for laboratory staff.
• Monitors expenditures and ensures services are cost effective.
• Acts as a liaison with clinic managers, other agencies and external reviewers associated with quality assurance. 

The intent of the listed knowledge, skills and abilities is to give a general indication of the core requirements for all positions in the class series; therefore, the KSA’s listed are not exhaustive or necessarily inclusive of the requirements of every position in the class.

• Knowledge of the methods, techniques, practices and procedures used in conducting laboratory testing of varied complexity in Clinical Chemistry, Microbiology, Hematology, Immunology, Immunohematology, Pathology, Histocompatability and Cytogenetics.
• Knowledge of laboratory operations, programs, policies, procedures and practices, applicable laws, rules, regulations and standards.
• Knowledge of the function and proper use of clinical laboratory equipment.
• Knowledge of the methods and techniques of data collection, interpretation and analysis.
• Ability to apply applicable federal and state regulations to the evaluation of laboratory personnel qualifications, instrumentation, quality assurance and laboratory practices.
• Ability to prepare written reports that provide adequate and accurate documentation.
• Ability to establish and maintain effective working relationships.
• Ability to communicate effectively.

In addition to the above knowledge, skills and abilities, the Quality Assurance Laboratory Manager requires:

• Knowledge of biology, medical technology or related disciplines.
• Knowledge of current advances in clinical laboratory science and procedural techniques and instrumentation.
• Knowledge of the principles of planning, management and administration.
• Knowledge of the procedures, methods and techniques used in assessing and analyzing quality assurance, operational and managerial problems.
• Knowledge of statistics and their use as an analytical and evaluative tool.
• Knowledge of supervisory techniques.
• Skill in troubleshooting and resolving quality assurance, operational and managerial problems.
• Ability to provide motivation, leadership and to set priorities.
• Ability to develop quality assurance tools and evaluation systems.
• Ability to organize training program.

JOB REQUIREMENTS for Laboratory Certification and Compliance Specialist
Applicants must have education, training and/or experience demonstrating competence in each of the following areas:

1. Possession of a Bachelors degree or higher in Biology, Medical Technology, Microbiology, Virology, Immunology, Parasitology, Molecular Biology, Histology, Chemistry or related field.
2. Six months experience in conducting clinical laboratory tests.
3. Six months experience in using laboratory equipment and instrumentation.
4. Six months experience in determining compliance with laboratory laws, rules, regulations, standards, policies and procedures.
5. Six months experience in narrative report writing.