Toxicology Laboratory Manager

Overview

We are seeking a hands-on laboratory manager with practical, daytoday knowledge of the College of American Pathologists (CAP) accreditation program to direct operations in our toxicology laboratory. You will champion continuous CAP readiness, uphold CAP and CLIA compliance, and lead the team to produce accurate, timely results. Your mastery of CAP checklist requirements, proficiency testing, and inspection preparation will drive workflow optimization, quality improvement, and patient safety.

Key Responsibilities

Maintain the laboratory’s CAP accreditation, including selfinspections, checklist gap analyses, proficiency testing enrollment and review, corrective action follow up, and onsite inspection management.

Supervise all toxicology testing, covering method development, validation, and daily production.

Track quality indicators, turnaround time, QC trends, and proficiency testing performance, and put corrective and preventive actions in place under the CAP Quality System Essentials.

Lead, mentor, and schedule technologists and support staff, while keeping competency assessments and continuing education current.

Oversee instrument maintenance, troubleshooting, and vendor service agreements to maximize uptime on LC/MS/MS and chemistry analyzers.

Write, review, and maintain SOPs, policies, and safety protocols that meet CAP checklist requirements and current best practices.

Control reagent and consumable inventories and negotiate with vendors to manage cost without compromising compliance.

Partner with the Laboratory Director and cross-functional teams to evaluate new methods and equipment and to ensure validation studies meet CAP standards and budget goals.

Prepare clear management reports that summarize performance metrics, inspection readiness, and quality improvement projects.

Required Qualifications

Bachelor’s degree in Chemistry, Biochemistry, or a related field (advanced degree preferred).

At least five years of clinical toxicology or analytical chemistry experience, including two or more years in a supervisory role.

Demonstrated knowledge of CAP checklist requirements, proficiency testing, quality system essentials, and inspection processes, with successful leadership of at least one CAP inspection.

Proven skill in operating and troubleshooting Shimadzu 8050 or 8060 triplequadrupole mass spectrometers, Agilent LCMS platforms, and Beckman AU chemistry analyzers.

Strong leadership and coaching ability with a record of building engagement and resolving conflicts in a fast-paced setting.

Excellent organization and communication skills with a history of meeting deadlines and managing multiple priorities.

Preferred Skills

Experience serving on a CAP inspection team or acting as an inspector.

Implementation or optimization of a Laboratory Information Management System (LIMS).

Proficiency with mass spectrometry data analysis tools such as Shimadzu LabSolutions or Agilent MassHunter.

Method development for urine, serum, and oral fluid matrices.

Budget management and cost saving initiatives.

Advanced data analysis skills, including statistical process control and root-cause analysis.