Laboratory Technical Supervisor I/II/Senior

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Position Overview

Provide technical functions and support for CLIA/CAP regulated high complexity clinical laboratory performing molecular testing using NGS; and assist with maintenance of laboratory compliance.

Adaptive’s Clinical Production laboratory is a CLIA/CAP/NYS/FDA certified laboratory and, as such, this position needs to adhere to and uphold all applicable regulatory requirements.

Key Responsibilities and Essential Functions - Laboratory Technical Supervisor I

• Trains on and will achieve competency on the review of flowcell and sample data QC  for trials and research studies, and first review of patient flowcell and sample data QC (for subsequent review and approval by an individual qualified as a Clinical Laboratory Director)
• Assists with providing technical troubleshooting to the clinical lab and to related quality improvement initiatives
• Monitors and trends quality metrics and assists with preparing weekly, monthly and quarterly reports for review and approval by a Clinical Laboratory Director, as appropriate
• Reviews and/or edits laboratory requirement documents (e.g., Analytic Methods, SOPs, IQOQPQ reports) for approval by a Clinical Laboratory Director
• Reviews maintenance reports for completeness and accurate documentation
• May assist with special projects such as LIMS Development in collaboration with the software team (e.g., creates dashboards for tracking and prioritizing requests, generates user requirements, UAT cases and plans, completes test plans, and related documents for system features and enhancements) under supervision of a more senior Technical Supervisor or Manager
• Alerts a Clinical Laboratory Director in a timely manner of quality, technical, or operational readiness issues that could impact patient testing and ensures all clinical laboratory teams comply with applicable regulations, e.g. non-conformances and/or incidents
• Collaborates with lab management and/or Clinical Laboratory Directors to develop and continuously improve day-to-day operations and ensure cross-functional alignment with laboratory support groups
• Assists more senior Laboratory Technical Supervisors with presentations for cross functional teams
• Reviews and approves training and competency assessments for CLO, as appropriate
• Collaborates with Operational Software Support on resolving issues such as sample re-directs, SKU switches, Portal requeues, and sample sheet issues
• Promotes a patient-centric culture where every patient result matters, and champions alignment with company goals and values
• Note that all responsibilities are to be defined to align with the definition of a Technical Supervisor under CLIA and NYS CLEP. All functions of a Technical Supervisor under CAP require oversight by a Clinical Laboratory Director.
• Follow Good Clinical Laboratory Practices (GCLP)
• Regulatory responsibilities of “Testing Personnel” for high complexity testing as defined by 42CFR493.1495 and NYCRR Title 10 Section 58-1.5(a)
• Regulatory responsibilities of “General Supervisor” for high complexity testing as defined by 42CFR493.1463 and of "Supervisor" as defined by NYCRR Title 10 Section 58-1.3
• CAP responsibilities of "Molecular Pathology General Supervisor" as defined by requirement GEN.53600
• Regulatory responsibilities (when delegated) of “Technical Supervisor” for high complexity testing as defined by 42CFR493.1451
• CAP responsibilities (when delegated) of "Molecular Pathology Technical Supervisor" as defined by GEN.53400
• All other duties as assigned

Key Responsibilities and Essential Functions - Sr Laboratory Technical Supervisor

• Applies deep subject matter expertise in molecular laboratory technical applications in order to propose solutions to complex problems thereby supporting the clinical laboratory needs for throughput, and to promote accurate result generation while keeping specified lab TAT in mind
• Provides review of flowcell and sample data QC for trials and research studies, and first review of patient flowcell and sample data QC  (for subsequent review and approval by an individual qualified as a Clinical Laboratory Director)
• Represents the clinical laboratory technical operations func