About the Job
The Molecular Technologist III is responsible for performing all aspects of complex patient sample testing, such as solution and reagent preparation, equipment maintenance, and tasks that pertain to the handling and testing of patient specimens, without direct supervision. The Molecular Technologist III is cross-functionally trained to perform all process steps and/or assays and assists with more complex troubleshooting or problem solving. The position provides on-the-job training to colleagues and also has responsibilities external to patient specimen processing that are project based or supporting qualification and validation activities. This role will work the Tuesday-Saturday 2nd shift (3:00pm-11:30pm).
The incumbent works one of three established 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.
• Prepare the Next Generation Sequencing (NGS) library.
• In adherence to established Standard Operating Procedures (SOPs):
· Extract and isolate nucleic acids.
· Complete hybridization capture, and genetic sequencing methods.
· Operate automated 8-span and 96-head liquid handling platforms.
· Operate quantification, sizing, and NGS instruments.
· Perform any other patient and client sample testing and processing steps needed.
• Perform workflow that maintains quality, thoroughness and optimum efficiency for Turn Around Time (TAT).
• 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.
• Perform daily, weekly, monthly and as needed equipment maintenance checks.
• Participate in additional continuous quality improvement activities.
• Adhere to safety protocols, such as wearing laboratory coats and required safety gear.
• Maintain organization and cleanliness in the labs.
• Collaborate on SOPs revisions and drafts as needed to adjust for process improvement initiatives and regulatory changes.
• Review SOPs at set intervals and sign-off to document knowledge of these procedures.
• Document and assist with investigations for non-compliance events via Non-Conformance Reports (NCRs), Corrective Action/Preventative Action (CAPAs) and other reports.
• Train others in laboratory processes.
• Participate in reagent and assay quality control and validations and in additional continuous quality improvement activities.
• Update and maintain records and data on test results.
• Monitor and communicate inventory of supply and reagent needs as they diminish.
• Assist with implementation of new instruments, equipment and assays.
• Guide continuous quality improvement activities.
• Collect and publish routine processing and operational metrics and execute countermeasures to ensure daily processing goals are met.
• Ensure operational efficiency by assisting with shift schedule updates.
• Other duties and projects pertinent to level of expertise as assigned.
• Bachelor‘s Degree in a chemical, physical, biological, or life science (per NYSDOH regulatory requirements)
• 3+ years of molecular laboratory work experience in a CAP/CLIA regulated lab
• Certifications or licensure that is required by the state or county in which the job is posted
• Molecular Biology American Society of Clinical Pathology (MB-ASCP) Certification
• Quality System Regulations (QSR) compliant laboratory experience
• 3+ years of experience working with:
· DNA manipulation techniques, enzymatic reactions, and sequencing chemistry
· Laboratory Information Management System (LIMS)
· high throughput platforms and common molecular laboratory equipment (including pipettes, thermocyclers, and liquid handlers)
• Experience ensuring and maintaining integrity and quality of a laboratory in the areas of sample processing, equipment maintenance and SOPs
• Proficiency utilizing Microsoft Office Suite, most specifically Excel and Power Point
• Knowledge of laboratory safety protocols
• Excellent skills of 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 both as an individual contributor and in a team
· 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
· Work in the presence of chemicals and reagents in a laboratory environment
• Understanding of HIPAA and importance of privacy of patient data
• A demonstrated commitment to FMI’s Values: Patients, Passion, Collaboration, and Innovation
#LI-Remote [Cambridge, Massachusetts, United States]
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