Position Overview

The Clinical Laboratory Technologist 1 position will be responsible for processing medically relevant biological samples through extraction and/or high throughput next-generation DNA sequencing assays. This role will work within a team of Laboratorians in a fast-paced, high production setting to process research and clinical diagnostic samples to provide test results to patients, oncologists and other medical practitioners and researchers. As such, high attention to detail and clinical mindedness are crucial to success in this role.

Adaptive's clinical laboratories are CLIA/CAP/NYS/FDA certified, and as such this position needs to adhere to and uphold all applicable regulatory requirements.

Key Responsibilities and Essential Functions

Scope/Impact

• Performs and provides general support for DNA extractions, PCR amplification, or high-throughput sequencing assays on DNA libraries in accordance with standard laboratory processes and procedures.
• Operates and maintains laboratory equipment such as liquid handling robotics and DNA sequencers.
• Completes tasks as assigned (e.g. routine clinical or research sample processing, validations, reagent QC runs, or special projects) accurately while following strict methodologies.
• Provides guidance to entry-level staff.

Complexity

• Performs protocols under compliance with regulatory agencies, models appropriate clinical, regulatory and safety practices.
• Makes decisions that impact quality, timeliness, and effectiveness of the team.
• Resolves basic problems that may involve uncommon variations of issues.
• Identifies and uses up to date, accurate information for problem solving and analysis.
• Ensures compliance with lab regulatory agencies (GxP, FDA, ISO).
• Keeps accurate and detailed records for all workflows following Good Documentation Practices.

Knowledge/Level of Expertise

• Demonstrates excellent clinical judgment and integrity by possessing specialized skills through job-related training and considerable on-the-job experience.
• Explains technical information within the team.
• Demonstrates understanding of underlying scientific principles of analytical methods and provides relevant information to Supervisor or Lead Technologist to assist with troubleshooting assay or instrument issues leading to appropriate corrective actions.
• Has strong communication skills to present problems or issues to Supervisor or Lead Technologist.
• Handles sensitive information confidentially.

Interactions, Supervision and Discretion

• Exhibit clear and effective communication to facilitate effective handoff procedures.
• Follows standardized laboratory processes and procedures with some guidance on daily work.
• Requires general instructions on newly introduced assignments.
• Uses clinical discretion to make recommendations for improving work procedures and processes to improve efficiency.

Regulatory Responsibility

• Maintain continuing education credit requirements.
• Record nonconformances for all appropriate errors.
• Enter and track data in a laboratory information database (LIMS)
• Operate and maintain laboratory equipment such as liquid handling robotics and DNA sequencers.
• Regulatory responsibilities per Good Manufacturing Practices (GMP)
• Regulatory responsibilities per Good Clinical Practices (GCP)
• Regulatory responsibilities per Good Laboratory Practices (GLP)
• Regulatory responsibilities of "Testing Personnel" for high complexity testing as defined by 42CFR493.1495

Position Requirements (Education, Experience, Other)

Required

Must meet ONE of the following:

Bachelor's or higher in medical technology or laboratory science