Document Control Specialist & Training Coordinator

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 visit www.biodesix.com.

OBJECTIVE OF THE POSITION:

The Document Control Specialist & Training Coordinator works cross-functionally to support QMS requirements to align and comply with regulations to ensure compliance to ISO, CLIA, NYS CLEP, CAP, etc. This position must promote and maintain quality policies, procedures, processes, programs, and practices associated with Document Control and Training to demonstrate conformance with appropriate standards and regulations.

The Document Control Specialist is responsible for quality assurance and compliance of the Document Control program, Training program, and management of laboratory notebooks throughout product lifecycle. This role is responsible for ensuring all documentation are structured and organized in accordance with the document control and training procedures. This is a dedicated, service-oriented resource to manage the process, improve system maintenance, develop meaningful, proactive metrics, and assist with functional groups to ensure the work is of quality standards but allows them to focus on their critical tasks. This is an opportunity to work for an exciting development and commercial diagnostics laboratory specializing in personalized medicine and have the opportunity for growth within a regulated industry.

RESPONSIBILITIES:

• Manage the document control program and proactively continue to improve the processes

• Responsible for assigning company-wide competency and continuing education training ensuring records are maintained and compliance to timelines are met

• Work with departmental leads to understand gaps and potentially improve training

• Support documentation of records for deviations, nonconforming material, CAPAs, etc.

• Support all QMS document owners/authors with document formatting and internal compliance standards

• Develop and provide training to entire organization on how to use the electronic document management system and the learning management system. Provide support training on the entirety of the electronic quality management system.

• Initiate and maintain training files monitoring for compliance and overseeing on-site and off-site storage and shipment

• Maintain the laboratory roles and responsibilities spreadsheet for real-time documentation of regulatory responsibilities

• Ensure proper and timely change control

• Manage metrics and trending for both document control and training

• Manage the monthly Laboratory Director test result review process

• Manage laboratory notebooks program and procedure

• Provide support for meeting facilitation for identified key meetings (tactical, Quality team, risk assessment, process improvements, others as identified)

• Provide support during external audits

• Assist with driving quality improvement initiatives inter-departmentally

COMPETENCY OR POSITION REQUIREMENTS:

• Preferred minimum of 1 year in document control, training or quality in a regulated industry

• Knowledge and experience with QSR, ISO, CLIA, CLEP, CAP desired

• Strong experience and demonstrated proficiency with Microsoft Office

• Strong verbal, written, and interpersonal skills

• Must possess strong organizational and time management skills with the ability to prioritize and manage completion of multiple tasks/projects, communicating with team members and other department personnel when necessary

• Must be detailed oriented

• A motivated self-starter able to perform all the required skills of this position with minimal direction

• Ability to adapt to a startup and flexible with responsibilities

EDUCATION AND EXPERIENCE:

• Preferred Bachelor of Arts or Sciences or related experience in Quality or a regulated environment

REGULATORY REQUIREMENTS:

This role shall comply, at a minimum, with the responsibilities 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, Chemistry, Director Responsibility and Authority and Molecular Pathology 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
• All other 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 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 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 an office setting

• The noise level in the work environment is usually moderate

UNPLANNED ACTIVITIES:

• Other duties as assigned

TRAVEL:

• Minimal

COMPENSATION:

Our compensation package includes:

• Competitive compensation $23.06 - $26.30

• Individual base compensation is 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

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.