Person, Text, Face

 

Every patient sample is a story.

That's why our Lab Ops team is focused on providing physicians with comprehensive genomic information about each person's cancer. Information that's as unique as the patients are. The insights discovered in our labs may help change their story.

 

Molecular Technologist III, RGT QC M-F 7am-3:30pm

  • Cambridge, Massachusetts, United States
  • Full Time

About the Job

The Molecular Technologist III, Reagent QC supports the Reagent Quality Control (QC) program in Laboratory Operations . The Molecular Technologist III, Reagent QC 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 to ensure high quality results when performing Reagent QC testing. Titles are internal to Foundation Medicine and may not align with Clinical Regulations.

This position is scheduled for Monday-Friday 1st shift (7:00am-3:30pm).

Molecular Technologist III, Reagent QC is assigned to a shift and may be assigned to adjust hours or work any day that the lab is operational.

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

Key Responsibilities

  • Operational:
    • Communicate and escalate issues and delays effectively to necessary management and personnel
    • Assist with storage and upkeep of paper-based and electronic, documents, records, reports, and logs, i.e. General x Practices (GxP) records, related to reagent QC.
    • Assist with preparation, aliquoting and LIMS entry of solutions and reagents used across all assays.
    • Perform daily, weekly, monthly, and as needed equipment maintenance checks.
    • Perform QC Kit assembly utilizing Maximo and LIMS to acquire availability and release emails for QC packets.
    • Perform QC Review for Quality Inspection Incoming materials sign-off on FRM-408/LIMS and Maximo.
    • Maintain proficiency in Reagent QC Standard Operating Procedures (RGT SOPs)
    • Perform highly complex testing according to RGT SOPs
      • Operate automated 8-span and 96-head liquid handling platforms for quality control sample processing.
      • Operate quantification (ssDNA and dsDNA), sizing, and NGS instruments.
    • Perform Data Analysis for DNA Extraction through Sequencing, OliGreen Controls, and post sequencing metrics for RGT QC testing.
    • Prepare BNAs, Process Controls and Baitsets.
    • Participate in reagent and assay quality control, validations and stability studies as needed.
    • Contribute to, review, edit and write SOPs, tracking forms, training logs and any required Quality Management System documentation as needed.
    • Provide support for Installation Qualification/IQ, Operational Qualification/OQ and Performance Qualification/PQ for processes within the team.
    • Maintain availability to troubleshoot assays and instrumentation as needed.
    • Collect and present routine processing and operational metrics and execute countermeasures to ensure daily processing goals are met.
    • Maintain flexibility to cover scheduling gaps as needed.
    • Ability to work in a laboratory environment in the presence of chemicals and reagents.
    • Document and assist with investigations for non-compliance events via Non-Conformance Reports (NCRs), Corrective Action/Preventative Action (CAPAs) and other reports.
    • Execute JIRA tickets for all new QC testing and upload all appropriate documents
    • Contribute to development of quality improvement initiatives, continuing education presentations and presentation of routing processing and operational metrics.
  • Compliance:
    • Comply with current Good Manufacturing Practices (cGMP) in performing reagent QC testing according to established SOPS on extractions, Next Generation Sequencing (NGS) library prep, hybridization and sequencing.
    • Maintain efforts for compliance with laboratory safety protocols
  • Other:
    • Complete projects fitting of level of expertise and be able to deliver results with minimal supervisor guidance
    • Assist with user testing to provide feedback for LIMS workflows and software releases.
    • Able to train others on RGT QC processes.
    • Other duties as assigned.
    • Demonstrate working as a leader within a team.

Qualifications

Basic Qualifications

  • Bachelor‘s Degree in a chemical, physical, biological, or life science (per NYSDOH regulatory requirements)
  • 4+ 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

Preferred Qualifications

  • Molecular Biology American Society of Clinical Pathology (MB-ASCP) Certification
  • Quality System Regulations (QSR) compliant laboratory experience
  • 4+ 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
  • Demonstrated 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-Onsite

 

Please be aware that Foundation Medicine mandates COVID-19 vaccination of all employees regardless of work location. Accommodations may be made in accordance with applicable law. Also, please feel free to upload or attach any official or unofficial educational transcripts that will help verify your ability to work in a lab. Please note that, if hired, official educational transcripts will need to be submitted.

 

About Foundation Medicine

Foundation Medicine, Inc. (FMI) began with an idea—to simplify the complex nature of cancer genomics, bringing cutting-edge science and technology to everyday cancer care. Our approach generates insights that help doctors match patients to more treatment options and helps accelerate the development of new therapies. Foundation Medicine is the culmination of talented people coming together to realize an important vision, and the work we do every day impacts real lives.

Confidence, or the belief that we need to check every box before applying for a job, can sometimes hold us back from going after a role that inspires us. At Foundation Medicine there's no such thing as the 'perfect' applicant, and our company is a place where every employee can make an impact and continue to grow whatever background they may have or path they may have taken. So, as long as you meet the basic qualifications for a role, please apply if you see a position that would make you excited to come into Foundation Medicine every day and help us transform cancer care.

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