Molecular Training Specialist, Molecular Operations - Solid Tumor (3rd Shift)

Role Summary

Molecular Training Specialist is responsible for developing and executing training procedures for the molecular department.

Responsibilities

• Maintain regulatory compliance to all applicable regulatory requirements (FDA, CLIA, NYS, ISO, CAP, etc.)
• Maintains exceptional quality standards for all molecular analysis.
• Initializes, tracks and documents the creation of competency samples.
• Initializes, tracks and documents the progress of employee training, including the review of cap checklists.
• Assists in high complexity projects and process improvements.
• Initializes, tracks and documents continuing education hours.
• Meets all deliverables and goals set by department. Adheres to the laboratory‚Äôs quality control policies, documents all quality control activities, instrument and procedural calibrations, and maintenance performed
• Documents all corrective action taken when a test system deviates from the laboratory‚Äôs established performance specifications.
• Assists with the tracking, accumulation, and computation of performance metrics to include turnaround times, issue reviews, and case tracking.
• Documents and reviews all accreditation agency pre-inspection paperwork and mandatory checklists.
• Performs periodic audits within the Molecular Department to ensure we maintain compliance.
• Participate in Quality Control / Quality Assurance process improvements.
• Capture, trend and analyze quality data monthly. Drive identified actions.
• Provide departmental and companywide training on regulatory requirements and quality control processes.
• Accepts other duties as assigned.

Qualifications

• Required: Bachelor's or Master's degree in a chemical, biological, clinical or medical laboratory science, or medical technology from an accredited institution.
• Required: 3+ years clinical laboratory experience with at least 1 year being high complexity molecular testing.
• Required: Knowledge of quality control and monitoring methodologies.
• Required: Proficient in Microsoft Office Suite, specifically Word, Excel, Outlook, general working knowledge of Internet for business use, and skilled in operating office equipment such as fax machines and copiers.
• Preferred: Master's degree in a chemical, biological, clinical or medical laboratory science, or medical technology from an accredited institution.
• Preferred: Experience in FDA regulated industries.
• Preferred: Ability to work in a fast-paced, deadline-driven environment.
• Preferred: Knowledge of laboratory safety procedures for biohazards and chemicals, as well as quality control procedures and regulations.

Skills

• Quality control methodologies
• Regulatory compliance
• Training program development and delivery
• Data analysis and metrics tracking
• Documentation and record-keeping

Education

• Bachelor's degree in chemical, biological, clinical or medical laboratory science, or medical technology (required)
• Master's degree (preferred)

Additional Requirements

• Physical Demands include computer use, inventory/record-keeping, and potential exposure to lab hazards; ability to lift up to 30 pounds; ability to work in a lab environment with potential exposure to fumes and biohazards.