Senior Clinical Laboratory Associate

Salary Range: 80000 to 90000 (Currency: USD) (Pay period: per-year-salary)

What you'll bring

Qualify as a CLIA Testing Personnel for a high-complexity laboratory based upon education and relevant experience, per 42 CFR 493.1461 

An associate’s, bachelor's or master's degree in chemical, biological, or medical laboratory science from an accredited institution

3+ years of hands-on industry and/or academic medical center-based experience with next-generation sequencing (NGS) and associated methodologies including DNA-seq and/or RNA-seq protocols 

Minimum of two years of experience in a high-complexity CLIA laboratory including a deep understanding of CLIA regulatory requirements, quality systems, and laboratory best practices 

Strong judgment in recognizing and escalating out-of-specification results, ambiguous findings, or workflow anomalies through appropriate channels, with clear and timely communication to senior staff, lab management, or cross-functional partners as required

Familiarity with CLIA/CAP requirements, with experience supporting or participating in inspections, internal audits, or readiness activities in a high-complexity laboratory setting.

You have excellent time management and organizational capabilities necessary to deliver results in a fast-paced environment with changing and competing priorities 

Demonstrated ability to work independently and collaboratively in a dynamic, fast paced team environment 

Experienced user of automated liquid handlers 

Prior experience working with LIMS (Laboratory Information Management System) / ELN (Electronic Laboratory Notebook) 

Exposure to automation method development or script optimization (Hamilton VENUS or similar) highly preferred

Experience working with LBx (liquid biopsy) and FFPE (Formalin-Fixed Paraffin-Embedded) oncology specimens highly preferred

What you'll do

Independently perform high-complexity testing in a CLIA-certified laboratory in compliance with CLIA, CAP and internal SOPs

Execute end-to-end NGS workflows, including sample accessioning, nucleic acid extraction, quantification, library preparation, and sequencing setup 

Operate and perform routine testing on automated liquid handling platforms 

Identify workflow inefficiencies and propose improvements to increase throughput, robustness, and scalability 

Perform and review quality control (QC) metrics; escalate and investigate out-of-specification results 

Ensure accurate and compliant documentation following CLIA regulations and Good Documentation Practices (GDP) 

Collaborate cross-functionally with assay development, automation and quality teams 

Utilize LIMS systems to track samples, workflows, and results with strong attention to chain of custody 

Participate in root cause analysis and corrective/preventive actions (CAPA) as needed

Participate in proficiency testing (PT) programs and internal alternative assessment activities in accordance with CLIA requirements; support periodic competency assessments for testing personnel.

Perform routine equipment maintenance, calibration, and function verification per manufacturer specifications and SOPs

Manage reagent and consumable inventory including lot tracking, expiration monitoring, and timely reorder to ensure uninterrupted laboratory operations