Laboratory QA & QC Coordinator, Full-Time

GENERAL SUMMARY OF DUTIES:

The QA & QC Coordinator is responsible for the laboratory QA and QC monitoring, evaluation, documentation, and reporting program.

REQUIREMENTS:

• Bachelor’s degree required

• Minimum of 5-10 years previous lab experience required

• Laboratory Technologist Certification required

• Working knowledge of MS Office required

• Through knowledge of lab testing procedures and equipment required

• Through knowledge of web browsers and their functionality required

• Thorough knowledge of lab PT, QC, and QA program requirements and CLIA & FDA regulations and DNV & AABB standards

• Skills necessary to initiate, expand and maintain MS Word documents required

• Skills necessary to perform laboratory testing per services provided required

• Skills necessary to organize information efficiently and effectively, files, reports, etc. both paper and electronic required

• Skills necessary to work effectively with others in a collaborative environment required

• Skills necessary to initiate, expand, and maintain MS Excel spreadsheets required.

• Ability to maintain confidentiality required

• Ability to work efficiently with minimal oversight required

• Ability to work in a fast-paced environment required

ESSENTIAL FUNCTIONS:

• Maintains and establishes Quality Assessment, Quality Control, and Proficiency Testing functions, including maintaining all required documentation, records, and reports

• Resolves technical problems and ensures that remedial actions are taken whenever test systems deviate from the laboratory's established performance specifications

• Prepares quality reports to include specific monitors, including reports to QPC meetings

• Oversees and performs method validation and calibration verification studies as needed

• Analyzes and responds to client complaints, unusual incident reports and Risk Management inquires

• Assists with review of policies and procedures, performing literature searches as needed to ensure regulatory agency requirements and manufacturers’ recommendations are addressed and met

• Assists with training of testing personnel and monitoring personnel competency in all phases (pre-analytic, analytic, and post-analytic) of testing to assure the ongoing competency of all individuals who perform testing. Identifies remedial training or continuing education needed

• Assists with verification of the test procedures performed and the establishment of the laboratory's test performance characteristics, including the precision and accuracy of each test and test system

• Assists with the coordination of the validation and implementation of new testing systems, equipment, supplies, reagents, and instrumentation

• Performs other duties as assigned, which include performing all the duties and responsibilities of a Laboratory Technologist

PHYSCIAL DEMANDS:

• The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• While performing the duties of this job the employee is frequently required to sit, converse, and listen; use hands to touch, handle, or feel objects, tools, or controls; and to reach with hands and arms. Specific vision abilities required by this job include close vision and the ability to adjust focus.

• The employee must be able to lift and/or carry over 20 pounds on a regular basis and be able to push/pull over 25 pounds on a regular basis.

• The employee must be able to stand and/or walk at least five hours per day.

WORK ENVIRONMENT:

• The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.