Confirmation Scientist

Mako Medical•Raleigh, NC

8h•Onsite

About The Position

This position is full-time that will require weekend coverage rotations. The job purpose is to prepare and analyze clinical samples in the toxicology lab, accurately prepare laboratory solutions, calibrators, QCs, and reagents, and operate and maintain laboratory equipment and instrumentation. The role involves troubleshooting a vast array of sample preparation and instrumentation derived issues, reviewing chromatography to identify and evaluate the scientific validity of data in determining the presence and absence of toxicology compounds, and providing secondary review and certification of Liquid Chromatography/Mass Spectrometry (LCMS) data prior to reporting.

Requirements

Qualified as High Complexity Testing Personnel under CLIA by way of bachelor’s degree in a chemical, physical, biological, or laboratory science or an associate degree in medical laboratory science from an accredited college, or equivalent.

Nice To Haves

Prior experience with AB Sciex 4500/5500/6500 or equivalent preferred.

Responsibilities

Prepare and analyze clinical samples in the toxicology lab.
Accurately prepare laboratory solutions, calibrators, QCs, and reagents.
Operate and maintain laboratory equipment and instrumentation.
Troubleshoot a vast array of sample preparation and instrumentation derived issues.
Review chromatography to identify and evaluate the scientific validity of data in determining the presence and absence of toxicology compounds.
Provide secondary review and certification of Liquid Chromatography/Mass Spectrometry (LCMS) data prior to reporting.
Follow all laboratory policies and Standard Operating Procedures (SOPs) in accordance with regulatory guidelines set by the Clinical Laboratory Improvement Amendments (CLIA) and the College of American Pathologist (CAP) Laboratory Accreditation Program.
Serve as a key operator responsible for LCMS instrumentation, Hamilton liquid handling system, and ancillary laboratory equipment to perform and urine and oral fluid toxicology testing.
Review and certify chromatography data for reporting in accordance with SOPs and quality control guidelines. Seeking immediate corrective action for patient samples not meeting these stringent criteria during data review.
Maintain and monitor reagent and chemical solution integrity, quality assurance, and inventory, preparing or securing additional materials as needed.
Perform equipment and instrumentation maintenance, calibration, verification, and repair all issues not covered under service contracts.
Seek to continuously improve laboratory operations and quality assurance activities by evaluating opportunities to improve efficiency, reduce costs, and standardize practices by providing feedback to General and Technical Supervisors, implementing changes, and assisting in SOP development.
Independently participate in College of American Pathologist (CAP) Proficiency Testing (PT), internal alternative PT assessments, and external laboratory comparison studies.
Organize, review, report, store, and archive laboratory data in accordance with approved SOPs, quality control guidelines, and supervisory guidance.
Ensure that work requirements are completed in a timely, organized manner to very high standards and in compliance with SOPs and CAP/CLIA regulations or guidelines.
Ensure that facilities, equipment, supplies, and reagents are maintained and used in a same manner and administered in accordance with applicable safety, occupational health, and environmental protection guidelines, policies, and regulations.
Assists in the training of other laboratory staff or personnel to perform testing or operate instrumentation as requested by the Technical or General Supervisor.
Responsible for reading and understanding of all required SOPs and continuing education courses to maintain knowledge of the field of medical technology and those techniques and instrumentation management and reporting of clinical data.
Effectively and promptly communicates issues to supervisors and teammates as they arise.
Upholds Mako’s Core Values and supports an environment of Mako Culture.
Other duties as assigned.