About the Job

The Senior Molecular Technologist serves as a technical resource, performs patient sample testing, and leads qualification initiatives. This position is responsible for troubleshooting in the lab, equipment maintenance, solution and reagent preparation, process improvement initiatives, sample tracking and responding to internal client status inquiries. The Senior Molecular Technologist is completely cross trained in all laboratory protocols and assays and supports on the job training and competency assessments. This position leverages a high level of experience and knowledge in a complex NGS laboratory to support lab management in coordinating the execution of sample processing and assay and equipment validations, as well as providing requirements and user testing for laboratory related software.

This position requires working in the regular presence of chemicals and regents. Senior Molecular Technologists are assigned to one of three shifts and may be assigned to work any day that the lab is operational. 

This is a regulated position and additional information may be available from QA on the qualifications for this role pertaining to regulatory guidelines. 

Regular onsite work at a designated FMI location is an essential function of this role.

Key Responsibilities

Perform patient sample testing in a manner that adheres to all established standard operating procedures (SOPs) and facilitate communication and smooth transition of specimens between shifts. Perform testing workflow that maintains quality, thoroughness and optimum efficiency result turnaround time. Support the lab supervisors with maintaining and publishing the lab schedule and/or processing metrics. Utilize the Laboratory Information Management System (LIMS) to track and execute sample processing. Document executed process steps per Good Documentation Practices (GDP); update and maintain records and data on test results per GDP. Support review of records to ensure quality, compliance and adherence to GDP. Lead user testing and provide feedback for LIMS workflows and software releases. Lead and coordinate assay and equipment validations and qualifications. Train others in laboratory processes. Document and assist with investigations for non-compliance events via NCRs, CAPAs, etc. Provide support for audit activities. Perform competency assessments when delegated by a technical supervisor. Contribute to development of quality improvement initiatives and continuing education presentations. Support the evaluation of new instrumentation, analytical methods and laboratory procedures. Support supervisor in collecting, publishing, maintaining, or evaluating routine metrics and execute countermeasures to ensure daily processing goals are met. Utilize a deep understanding of the process to troubleshoot assays and instrumentation as needed. Operate automated 8-span and 96-head liquid handling platforms to perform highly complex testing according to established standard operating procedures (NGS library preparation, hybridization, and sequencing), with minimal guidance; operate quantification, sizing, and NGS instruments. Contribute to maintenance of equipment and other technical resources. Collaborate with internal teams, vendors, and others as needed to resolve issues, maintain ongoing functionality and document service, project management and repair work. Perform daily, weekly, monthly and as needed equipment maintenance checks. Write, collaborate, revise and review standard operating procedures as needed to adjust for process improvement initiatives and regulatory changes. Contribute to additional projects as needed, including continuous process improvement initiatives. Other duties as assigned.

Qualifications

Basic Qualifications

Bachelor of Science in a Biological, Chemical, Physical or Life Science 6+ years of relevant lab experience in a Quality System Regulations (QSR) compliant lab or other regulated laboratory environment (CLIA/CAP/NYS) Certifications or licensure that is required by the state or county in which the job is posted

Preferred Qualifications

American Society of Clinical Pathology (ASCP) molecular biology certification Experience with ensuring and maintaining integrity and quality of the lab (in compliance with QMS) Experience with Laboratory Information Management System (LIMS) Demonstrated history working as a leader within a team Strong knowledge of accreditation and regulatory standards Strong knowledge of laboratory safety protocols Expertise with high through-put platforms and common molecular laboratory equipment (pipettes, thermocyclers, liquid handlers, etc.) Expertise utilizing Microsoft Office Suite, specifically Excel and Power Point Strong interpersonal skills that include excellent skills in written communication, oral communication, collaboration, and problem solving with other departments and colleagues Excellent organization and attention to detail Ability to: work well under pressure while maintaining a professional demeanor prioritize and thoroughly follow up on assigned tasks handle multiple tasks at once and work in a fast-paced environment adapt to changing procedures, policies and work environment Demonstrated integrity and a commitment to values held at FMI: patients, innovation, collaboration, and passion Understanding of HIPAA and importance of patient data privacy

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