Molecular Training Specialist, Solid Tumor (2nd Shift)

Job Responsibilities

• Maintain regulatory compliance to all applicable regulatory requirements (FDA, CLIA, NYS, ISO, CAP, etc.)
• Maintains exceptional quality standards for all molecular analysis.
• Initiates, tracks and documents the creation of competency samples.
• Initiates, tracks and documents the progress of employee training, including the review of cap checklists.
• Completes data analysis and concordance for competencies and training samples.
• Affords assistance in high complexity projects and process improvements.
• Supports validation efforts and new assay implementation by acquiring proficiency in new assays and creating and delivering training to molecular technologists.
• Initiates, tracks and documents continuing education hours.
• Mets all deliverables and goals set by department.
• Adheres to the laboratory’s 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’s 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.
• Participates 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.

Required Qualifications

• Bachelor's degree in a chemical, biological, clinical or medical laboratory science, or medical technology from an accredited institution.
• 4+ years clinical lab experience with at least 1 year being high complexity molecular testing.
• Demonstrated proficiency in molecular workflows and assay troubleshooting.
• High technical accuracy and efficiency across multiple assays.
• Good knowledge quality control and monitoring methodologies.
• 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 Qualifications

• Master's degree in a chemical, biological, clinical or medical laboratory science, or medical technology from an accredited institution.
• Experience in FDA regulated industries.
• Knowledge of laboratory safety procedures for biohazards and chemicals, as well as quality control procedures and regulations.
• Ability to work in a fast-paced, deadline driven environment.
• Drive for Results (Service, Quality, and Continuous Improvement) – ensure procedures and processes are in place that lead to delivery of quality results and continually reassess their effectiveness to achieve continuous improvement.
• Communication – Proficient verbal and written communication skills.
• Willingness to share and receive information and ideas from all levels of the organization in order to achieve the desired results.
• Teamwork – Commitment to the successful achievement of team and organizational goals through a desire to participate with and help other members of the team.