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Form of workABOUT 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 visit www.biodesix.com.
OBJECTIVE OF THE POSITION:
The objective for this position is to work collaboratively with cross-functional teams to ensure the production of innovative diagnostic tests that meet FDA cGMP regulations and comply with the company's high standards of quality. The successful candidate will take ownership of initiating and completing quality documentation for kit builds, conduct product acceptance testing, maintain accurate inventory counts, and provide support for the efficient operation of the KanBan system for Manufacturing inventory. Additionally, the candidate will maintain a clean and organized work area, adhere to daily contamination controls, and respond quickly to environmental alerts. Finally, the candidate will be flexible and willing to take on other duties as assigned to support the success of the Manufacturing team.
RESPONSIBILITIES:
- Be a key player in the production of our innovative diagnostic tests
- Ensure that quality kits are expertly assembled and comply with FDA cGMP regulations
- Actively monitor and accurately input information into our Kit Order and Distribution System
- Collaborate with cross-functional teams to fulfill kit orders and support our dedicated clinicians in improving patient outcomes
- Take ownership of initiating and completing applicable quality documentation for kit builds
- Play an essential role in prepping finished goods for distribution and ensuring they meet our high standards of quality
- Conduct Product Acceptance Testing on batches of finished goods to ensure they meet our rigorous standards
- Help maintain accurate inventory counts and support the efficient operation of our KanBan system for Manufacturing inventory
- Maintain a clean and organized work area and adhere to daily contamination controls to ensure the safety of our products
- Act quickly to monitor, respond to, and correct environmental alerts in a timely fashion
COMPETENCY OR POSITION REQUIREMENTS:
- Strong organizational skills with exceptional attention to detail
- Ability to read, write, understand, and clearly communicate in English
- Proficiency in computer skills, including Excel, and e-mail systems
- Ability to adapt to emerging situations and respond with a sense of urgency
- Ability to consistently meet deadlines
- Must adhere to all standard operation procedures within Quality Management System
- Ability to train others on current processes
- Shipping and International Shipping experience is a plus but not required
EDUCATION AND EXPERIENCE:
- High School diploma
- Two or more years as an assembly technician in a high-volume manufacturing environment
- REgulatory requirements:
- This role shall comply, at a minimum, with the responsibilities and qualifications outlined in:
- ISO: International Organization for Standardization (ISO) 13485, Quality Management Systems, Requirements for Regulatory Purposes, 2016
- QSR: Quality System Regulation, Title 21 Code of Federal Regulations Part 820
- All other applicable state and regulatory governing authorities including but not limited to: CA, PA, RI, MD applicable state and regulatory governing authorities including but not limited to: CA, PA, RI, MD
PHYSICAL REQUIREMENTS:
- 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 and talk or hear
- The team member is required to stand for up to 8 hours, walk, and reach with hands and arms; occasionally is required to stoop, kneel, crouch, or crawl, and must be able to lift and/or move more than 25 pounds
- Specific vision abilities required by this job include visual acuity to Colorado driver’s license requirements
WORK ENVIRONMENT:
- 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 a manufacturing/warehouse setting
- The noise level in the work environment is usually moderate
UNPLANNED ACTIVITIES:
- Other duties as assigned
TRAVEL PERCENTAGE:
- Minimal
COMPENSATION:
We are excited to provide:
- Competitive compensation $19.57 - $21.73 per hour
- Individual compensation packages 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
- 12 paid holidays
- Employee Assistance Program
- Voluntary Benefits
- Employee recognition program
JOB LOCATION:
- Louisville, CO
Biodesix is an equal opportunity employer. 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.
