Job purpose

• Provide supervision and oversight of toxicology confirmation operations under the direction of the Mass Spectrometry Manager while working as an integral part of the team.

• Serves as a first level of escalation for daily operational issues, briefing the Mass Spectrometry Manager as issues are raised and addressed.

• Prepare and analyze clinical samples in the toxicology lab.

• Accurately prepare laboratory solutions, calibrators, QCs, and reagents.

• Operate and maintain laboratory equipment and instrumentation.

• Troubleshooting a vast array of sample preparation and instrumentation derived issues.

• Review chromatography to identify the evaluate 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.

Duties and responsibilities

• Serve as an assistant to the Mass Spectrometry Manager responsible for overseeing operations, including LCMS instrumentation, Hamilton liquid handling system, and associated reagents, consumables, work processes and sample analysis.

• 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 Mass Spectrometry Manager, 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 Mass Spectrometry Manager

• Assists Mass Spectrometry Manager with method development research and development.

• Serves as a subject matter expert and resource for both internal and external customers.

• 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 managers and teammates as they arise.

• Upholds Mako’s Core Values and supports an environment of Mako Culture.

• Other duties as assigned.

Minimum Qualifications

• Qualified as High Complexity General Supervisor 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.

• Requires at least two years of experience in a High Complexity toxicology laboratory with demonstrable track record of increasing responsibility, with supervisory or managerial experience preferred.

• Prior experience with AB Sciex 4500/5500/6500 preferred.

Education

• Bachelors or better in Chemistry or related field

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. 41 CFR 60-1.35(c)