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Location

Morrisville, NC | United States

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Job description

Job Description

About the Job

The Molecular Technologist I performs procedures in a complex patient sample testing process with limited supervision. Most prominently, the position is responsible for solution and reagent preparation, equipment maintenance, and the handling and testing of patient specimens. 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.


Key Responsibilities

• Prepare the Next Generation Sequencing (NGS) library.
• Under limited supervision of senior lab personnel and 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.
• Other duties as assigned.

Qualifications:

Basic Qualifications

• Bachelor's Degree in a chemical, physical, biological, or life science (per NYSDOH regulatory requirements)
• 1+ 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
• Familiarity of and experience working with DNA manipulation techniques, enzymatic reactions, and sequencing chemistry
• Familiarity with high throughput platforms and common molecular laboratory equipment (such as pipettes, thermocyclers, and liquid handlers)
• Experience with Laboratory Information Management System (LIMS)
• Experience ensuring and maintaining integrity and quality of the laboratory in the areas of sample processing, equipment maintenance, and SOPs
• Knowledge about laboratory safety protocols
• 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
• Proficiency utilizing Microsoft Office Suite, most specifically Excel and Power Point
• Excellent skills of written communication, oral communication, collaboration, and problem solving with other departments and colleagues
• Excellent organization and attention to detail
• Understanding of HIPAA and importance of patient data privacy
• Commitment to reflect FMI's Values: Patients, Passion, Collaboration, and Innovation.

#LI-Onsite

About Us

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.


Foundation Medicine is proud to be an Equal Opportunity and Affirmative Action employer and considers all qualified applicants for employment without regard to race, color, religion, sex, gender, sexual orientation, gender identity, ancestry, age, or national origin. Further, qualified applicants will not be discriminated against on the basis of disability or protected veteran status. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements. See also FMI's EEO Statement and EEO is the Law and Supplement. If you have a disability or special need that requires accommodation, please let us know by completing this form. (EOE/AAP Employer)

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