- All other applicable state and regulatory governing authorities including but not limited to: CA, PA, RI, MD
- Completes training and Competency Assessment for all new and existing procedures
- Takes responsibility for completing continuing education (CE) requirements set by applicable regulatory and accrediting agencies
- Performs all test realization function in support of Biodesix products and services
- Performs duties in line with established SOPs
- Enters appropriate data into LIMS
- Uploads appropriate data to the Customer Service team
- Contributes to the overall maintenance of laboratory equipment and supplies following SOPs
- Contributes to the creation and revision of Laboratory SOPs in the Quality Management System (QMS)
- Contributes to the Internal Audit readiness through good documentation practices
- Performs all job functions in accordance with HIPAA
- Contributes to Development projects, as needed
- Communicates effectively with on-site and remotely located management/support teams
- Technical level (I/II/III) will be benchmarked based on laboratory experience, technical competency, and ability to work independently
- Outstanding technical laboratory skills
- Excellent attention to detail with a strong commitment to thoroughness and error-free execution of procedures
- Exceptional organizational and documentation skills
- Participate in CE program
- Knowledge of lab safety and GLP
- Basic computer skills required (Microsoft Office suite)
- Ability to work well in a team environment with strong work ethic
- Self-motivated and has exceptional written and verbal skills
- Bachelor's degree in a chemical, physical, biological, or clinical laboratory science or medical technology; or equivalent laboratory training and experience meeting the requirements defined by CLIA; OR
- Equivalent laboratory training and experience meeting the requirements defined by CLIA
- Experience with high complexity testing, HPLC, LC-MS and/or ELISA preferred
- The physical demands described here are representative of those that must be met by a team member to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- While performing the duties of this job, the team member is regularly required to use hands to grip, handle, or feel objects, tools, or controls, as well as talk and hear.
- The team member frequently is required to sit, walk, and reach with hands and arms; occasionally is required to stand, stoop, kneel, crouch, or crawl, and must occasionally lift and/or move more than 25 pounds.
- Specific vision abilities required by this job include visual acuity to State driver's license requirements.
- The work environment characteristics described here are representative of those a team member encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- The primary work environment is both an office setting and a laboratory setting.
- The noise level in the work environment is usually moderate.
- Other duties as assigned
- Minimal
- Competitive compensation $ $23.89
- Individual base compensation are based on various factors unique to each candidate, including skill set, experience, qualifications, and other job-related aspects.
- Discretionary Bonus opportunity
- Comprehensive benefits package - effective date of hire
- Medical
- Dental
- Vision
- Short/Long Term Disability
- Life Insurance
- Flex Spending Account
- 401(k)
- 120 hours of annual vacation
- 72 hours of paid sick time off
- 11 paid holidays
- 3 floating holidays
- Employee Assistance Program
- Voluntary Benefits
- Employee recognition program
- Louisville, CO
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Laboratory Technician I - De Soto, United States - Biodesix, Inc.
2 weeks ago
Description
ABOUT US:
Biodesix is a leading diagnostic solutions company with a focus in lung disease. The Company develops diagnostic tests addressing important clinical questions by combining multi-omics through the power of artificial intelligence. Biodesix offers five Medicare-covered tests for patients with lung diseases.
The blood based Nodify Lung nodule risk assessment testing strategy, consisting of the Nodify XL2 and the Nodify CDT tests, evaluates the risk of malignancy in pulmonary nodules, enabling physicians to better triage patients to the most appropriate course of action.
The blood based IQLung strategy for lung cancer patients integrates the GeneStrat targeted ddPCR test, the GeneStrat NGS test and the VeriStrat test to support treatment decisions across all stages of lung cancer with results in an average of two to three business days, expediting the time to treatment.
Biodesix also leverages the proprietary and advanced Diagnostic Cortex AI (Artificial Intelligence) platform, to collaborate with many of the world's leading biotechnology and pharmaceutical companies to solve complex diagnostic challenges in lung disease.
For more information about Biodesix, please visitOBJECTIVE OF THE POSITION:
The Laboratory Technician I assists with the setup, support, and execution of the daily activities of the laboratory.
In addition, a Laboratory Technician I will have the technical training and experience required to perform regulated clinical laboratory test realization (i.e., test specimen receipt through test result generation) using standard in-vitro laboratory techniques.
Team members are also expected to operate a proprietary LIMS.The position also operates in a cross-functional matrix organization working across departments, including Development, Customer Service, Accounting, Quality, Operations, the Laboratory Directors, and other departments as needed.
Ongoing training will be provided to supplement key skills required to perform the functions of this position as applicable.Required:
must embrace a culture of transparency, willing and open to share data and technical knowledge, excellent communication skills, on time delivery of complete and quality results.
Communicates issues promptly to manager with follow through to a resolution.
Qualified Laboratory Technicians may act as responsible delegates according to the Biodesix Quality Matrix, including day to day responsibilities required for CAP/CLIA as well as all state-specific requirements in which Biodesix is an approved test facility.
REGULATORY REQUIREMENTS:
This role shall comply, at a minimum, with the responsibilities and qualifications outlined in:
*CLIA: Clinical Laboratory Improvement Amendments (CLIA) Requirements, Title 42 Code of Federal Regulations Part 493
*CAP: College of American Pathologists (CAP): All Common, General, Director Responsibility and Authority and all test-specific checklists
*NYS CLEP: New York State Department of Health, Clinical Laboratory Evaluation Program (CLEP), New York State Public Health Law, Article 5 Title 5
*ISO: International Organization for Standardization (ISO) 13485, Quality Management Systems, Requirements for Regulatory Purposes, 2016
RESPONSIBILITIES:
COMPETENCY OR POSITION REQUIREMENTS:
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UNPLANNED ACTIVITIES:
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We are excited to provide:
JOB LOCATION:
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.
