Certifying Scientist - Worcester, MA

Description

Position Overview

Ethos R&D is seeking a qualified Certifying Scientist to support laboratory operations at Beacon Point Diagnostics. This is initially a contract position through Ethos R&D, with responsibilities performed primarily for Beacon Point Diagnostics.

The Certifying Scientist is responsible for the technical review, interpretation, and final certification of patient toxicology results. The position reviews analytical data generated through enzyme immunoassay screening, and LC MS/MS

This role requires advanced knowledge of toxicology, drug metabolism, analytical testing principles, and LC-MS/MS data interpretation. The Certifying Scientist will review calibration, quality control, and patient data; identify results requiring additional investigation; certify final patient reports; and assist clients and internal departments with report-related questions and corrections.

The Certifying Scientist may also participate in validation studies, proficiency testing, method development, quality improvement activities, and other laboratory initiatives under the direction of the Confirmation Supervisor, Technical Supervisor, or Laboratory Director.

Requirements

Essential Duties and Responsibilities

Patient Result Review and Certification

• Perform final review and certification of urine and oral fluid toxicology reports in accordance with established laboratory procedures.
• Review and interpret point-of-care, enzyme immunoassay, and LC-MS/MS confirmation testing results.
• Verify that patient demographic information, specimen information, ordered tests, and reported results are accurate and complete.
• Confirm that results are consistent with established analytical and reporting requirements.
• Evaluate prescribed medication information and identify results that may indicate non-prescribed medication use, illicit drug use, unexpected drug absence, or other inconsistencies.
• Add interpretive or explanatory comments to patient reports when appropriate and permitted by laboratory policy.
• Document completed report reviews and identify reports requiring additional investigation or supervisory review.
• Complete corrected, amended, or updated reports when necessary.
• Maintain appropriate documentation of report changes, corrections, and communications.

LC-MS/MS Data Analysis

• Review calibration, quality control, internal standard, and patient data for each analytical batch.
• Analyze patient specimens for multiple target analytes using approved mass spectrometry software.
• Confirm that retention times, precursor ions, product ions, qualifier ions, ion ratios, peak shapes, and other acceptance criteria are within established ranges.
• Identify and document analytical discrepancies, interferences, or results requiring further review.
• Identify specimens requiring reinjection, dilution, re-extraction, or repeat analysis in accordance with established procedures.
• Program and coordinate reinjections or repeat analyses on mass spectrometry instruments when authorized.
• Document completed data analysis and communicate unresolved issues to the appropriate supervisor.
• Transmit approved analytical results to the Laboratory Information System.
• Perform final review of internal and external rerun requests.

Quality and Regulatory Compliance

• Review and monitor quality control performance and recognize trends, shifts, invalid runs, or other quality concerns.
• Immediately report invalid data, quality control failures, instrument concerns, and procedural deviations to the appropriate supervisor.
• Participate in proficiency testing programs and ensure testing is completed in accordance with applicable requirements.
• Assist with method validation, method verification, research, and development activities as assigned.
• Follow all approved standard operating procedures, quality policies, safety requirements, and documentation practices.
• Maintain compliance with applicable CLIA, CAP, federal, state, and laboratory-specific requirements.
• Participate in ongoing training and continuing education related to toxicology, drug metabolism, analytical methods, and LC-MS/MS systems.
• Maintain complete, accurate, and contemporaneous laboratory records.

Client and Internal Support

• Respond professionally to calls and inquiries directed to the Confirmation Department.
• Assist clients with basic questions regarding toxicology, drug metabolism, testing methodologies, and reported results within the scope of the position.
• Assist with report corrections, demographic updates, report delivery, and similar client service matters.
• Collaborate with laboratory operations, accessioning, client services, quality, information technology, and other departments to resolve testing and reporting issues.
• Communicate analytical or reporting concerns clearly and promptly to the appropriate personnel.
• Promote a collaborative, accountable, and quality-focused work environment.

Additional Responsibilities

• Maintain regular and reliable attendance.
• Wear required personal protective equipment and follow all laboratory safety practices.
• Protect patient confidentiality and comply with all applicable privacy and information-security requirements.
• Perform other duties and laboratory projects as assigned.
• Education and Experience Requirements

Candidates must meet one of the following requirements:

• Master’s degree in chemistry, toxicology, pharmacology, biology, clinical laboratory science, medical technology, physics, or another relevant chemical, physical, biological, or analytical science; or
• Bachelor’s degree in a relevant chemical, physical, biological, or analytical science with at least one year of applicable laboratory experience.

Preferred qualifications include:

• Experience reviewing or certifying clinical toxicology results.
• Experience with LC-MS/MS testing of drugs and metabolites in biological specimens.
• Experience working with urine, oral fluid, blood, or other human specimens.
• Familiarity with Agilent liquid chromatography and mass spectrometry systems.
• Familiarity with Agilent MassHunter Acquisition and Quantitative Analysis software.
• Experience with HPLC, LC-MS/MS, or comparable analytical instrumentation.
• Experience participating in method development, method validation, method verification, or laboratory research.
• Experience working in a CLIA-certified or CAP-accredited clinical laboratory.

Contract Relationship

This position is initially engaged through Ethos R&D and assigned to provide services supporting Beacon Point Diagnostics. The individual may work closely with Beacon Point Diagnostics leadership, laboratory personnel, and clients while remaining subject to the terms of the applicable contract or employment agreement with Ethos R&D.

The assignment, reporting relationship, work location, schedule, and scope of services may be modified based on laboratory operational needs and the terms of the agreement.

Equal Opportunity Statement

Ethos R&D LLC and Beacon Point Diagnostics LLC are committed to providing equal employment and contracting opportunities. Qualified applicants will be considered without regard to race, color, religion, sex, pregnancy, national origin, age, disability, genetic information, veteran status, or any other status protected by applicable law.