MDxHealth seeks talented people who are passionate about improving the diagnosis and treatment of cancer patients.
MDxHealth is building world class healthcare company, providing significant career development and financial opportunities.
We offer a comprehensive compensation and benefits package, which includes a competitive salary, company paid medical, dental, vision and life insurance coverage, 401(k) with company match, generous employee discounts, a casual, but driven work environment, and the ability to make a real difference as a key contributor to our growth.
The Clinical Laboratory Scientist I (CLS I) performs a variety of both routine and complex clinical laboratory tests in accordance with established processes and procedures. These require professional level of knowledge to properly execute and analyze results, especially where results are abnormal or atypical. Responsible for compliance to all applicable regulations including but not limited to the Food and Drug Administration, ISO and State and Federal requirements.
SECTION I: JOB QUALIFICATIONS
- Minimum of 1 year laboratory experience, as active, licensed clinical laboratory scientist, preferred.
- Experience working with LIMS database, quality systems and lab automation.
- Molecular experience preferred.
Bachelors of Science/ Master’s/ Ph.D. from accredited institution with a major in one of the chemical, physical, or biological sciences.
ASCP certification preferred.
Current State of California license required.
SECTION II: REQUIRED KNOWLEDGE, SKILLS OR ABILITIES
- Knowledge of basic computer skills such as Microsoft Office Suite to include Excel and Word.
- Previous experience with Laboratory Information Management Systems, preferred.
- Ability to read, analyze, and interpret such documents as pertaining to the performance and analysis of analytical testing. This could include but not limited to reagent package inserts, and standard operating procedures.
- Ability to effectively present information and respond to questions from management, clients, auditors and internal customers.
SECTION III: JOB SPECIFIC REQUIREMENTS
- Perform all manual technical procedures relating to specimen preparation, specimen type, protocols and procedures.
- Operate automated laboratory instrumentation assigned to designated department and/or shift, including troubleshooting, maintenance and repair procedures as required.
- Consistently and accurately transcribe patient test results from raw data generated from an instrument into the Laboratory Information Management System (LIMS).
- Must have good reasoning ability; be knowledgeable of clinical pathology processes, and uses organizational skills to meet established turnaround time deadlines.
- Responsible for the accurate documentation of all testing activities including but not limited to patient specimens, proficiency testing, quality control results, performance of preventive maintenance/calibration of instruments, and LIS results entry.
- Capable of identifying problems that may adversely affect test performance or reporting of test results and either must correct the problem(s) or immediately notify the Laboratory Operations Manager, Laboratory Operations Supervisor and/or VP, Laboratory Operations.
- Responsible for the documentation of corrective actions when test systems deviate from the laboratory’s established performance specifications.
- Maintain on a daily basis, a neat, clean, well-organized work area including adequate daily working supplies stocked/stored at each bench.
- Responsible for the inspections, labeling, and storing of incoming supplies, when assigned.
- Ability to contact suppliers regarding performance of laboratory reagents, equipment, for troubleshooting purposes, when assigned.
- Maintain complete and document records in real time that includes but is not limited to, department logs, files, and worksheets.
- Recognize and communicate effectively laboratory results requiring immediate attention (critical values, inconsistent patient values, etc.).
- Responsible for training and cross-training licensed CLS and non-CLS employees.
- Responsible for administering and performing competency assessment testing (biennially for new employees employed less than one year) when scheduled.
- Responsible for meeting or exceeding results for key performance indicators and quality metrics.
- Identify and implement continuous process improvement.
- Participate in the evaluation of new methods and procedures under the direction of the Laboratory Director.
- Adapt to changes in processes, accepting approved changes and learning new tasks.
- Participate in continuing education programs (mandatory or non-mandatory).
- Must follow good documentation practices.
- Responsible for required training records to be completed and submitted to Document Control within the specified timeframe.
- May participate as an Internal Auditor in the internal audit program
- Follows processes under the Quality Management Systems for CAPA, Deviations, Nonconforming Materials and Client Complaints.
- Responsible for the creating and revising standard operating procedures following all document control processes.
- Follow MDxHealth’s health and safety policies and procedures.
- Perform other related duties as required or assigned.
SECTION IV: PROFICIENCY TESTING
- Responsible for the performance of proficiency testing samples under the guidelines set forth by the College of American Pathologists and New York State Department of Health.
- Responsible for notifying the Laboratory Director of any specimens submitted by a client that may be in violation of 42 CFR 493.801-8845 Subpart H–Participation in Proficiency Testing of Laboratories Performing Non-Waived testing.
SECTION V: WORK ENVIRONMENT
☒ Corporate Office Environment
☒ Laboratory Environment
☐ Home Office/Diagnostic Laboratories
☒ Use of Stairs (Alton Facility)
☐ Travel between Office Locations
☐ Local Travel/Ground Transportation (Less than 150 miles)
☐ National/International Travel (Airports/Airplanes)
☐ Not Applicable
☐ Not Applicable
☒ Not Applicable
☐ Not Applicable
☒ Not Applicable
☒ Not Applicable
☒ Not Applicable
SECTION VI: PHYSICAL DEMANDS
While performing the duties of this job, the employee is regularly required to use hands to finger, handle or feel. The employee is required to sit and stand during the duration of their shift. The employee must on occasion lift and/or move up to 10 - 25 pounds. Specific vision abilities required by this job includes close vision, distance vision, color vision, depth perception, and ability to adjust focus.
SECTION VII: OSHA RISK CATEGORY
Category I: Job Tasks which involve exposure to blood, body fluids, tissues, hepatitis viruses or human immunodeficiency viruses.
- Responsible for performing assigned tasks in accordance with applicable safety regulations and instructions, as well as correcting unsafe work habits and practices and/or bringing to the attention of the Laboratory Director, Safety Representative, a Manager/Supervisor, Human Resources, Quality Management any practice or condition that may be detrimental to the safety and health of employees.
- Responsible for compliance to all safety policies of the MDxHealth safety program.
- Follow procedures for biohazardous/hazardous waste disposal.
- Utilize appropriate infection control practices such as hand-washing, proper glove disposal, use proper personal protective equipment and work practice controls.
- Maintain proper body mechanics and utilizes safe work practices.
SECTION IX: REGULATORY AND COMPLIANCE
- Responsible for compliance to all applicable statutory and regulatory requirements for international, federal, and state requirements, including, but not limited to, California Labor Laws, OSHA, Clinical Laboratory Improvements Amendments (CMS), Americans Disabilities Act, Health Insurance Portability and Accountability Act (HIPAA/Omnibus), MDxHealth OIG Compliance Program, College of American Pathologists, California State Department of Public Health, New York State Department of Health, ISO 9001:2008, U.S. Food and Drug Administration. (Refer to the MDxHealth Quality Systems Manual for a complete listing).
- Take responsibility for supporting the College of American Pathologists Patient Safety Goals.
- Responsible for reporting to the College of American Pathologists any concerns regarding quality patient testing or laboratory employee safety that are not being addressed by MDxHealth.
- Exhibit ethical and professional behavior at all times.
- Maintain patient confidentiality at all times (HIPAA).
SECTION X: SUPERVISORY RESPONSIBILITIES