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Quality Management System Analyst

Quality Management System Analyst

Biodesix, Inc.Louisville, CO, US
15 hours ago
Job type
  • Full-time
Job description

Overview

The Quality Management System (QMS) Analyst is the lead Information and Technology Services (ITS) team member responsible for change control documentation. The ideal candidate is hands-on, willing to learn from others, and has experience providing application support and troubleshooting across an organization. They must possess a friendly and engaging personality and have the capacity to problem-solve and think creatively. This person should embody a passion for continuous improvement and will be responsible for working closely with cross-functional departments to understand needs and create customer experiences that exceed expectations.

Location

Louisville, CO | Hybrid, 3 Days On-Site

Responsibilities

  • Assist with creating, editing, and maintaining quality management system (QMS) documents (Policies, SOPs, Plans, Protocols, Reports, etc.) to ensure compliance with regulatory and internal quality requirements
  • Ensure change control of software QMS documents, including using approved templates, creating a draft based on ITS team input, initiating cross-functional review, consolidating feedback from multiple contributors, and ensuring approval records are completed
  • Summarize software QMS documentation activities both within the ITS team and for other non-technical audiences such as quality review or audit support
  • Plan, write, and maintain user support documentation, including online help screens
  • Provide clerical and administrative support related to documentation processes and systems
  • Translate business specifications into user documentation and ensure that documentation is accurate and easily accessible
  • Stay current with technology and changing documentation trends, provide recommendations for continuous improvement, and seek supplemental training to improve your performance
  • Work alongside other members of the ITS team to proactively elevate documentation strategy and consistently apply best practices

Requirements

  • Strong analytical skills with the ability to define and identify solutions
  • Excellent written, organizational, and communication skills
  • Must work well in a multi-task environment
  • Must be a self-starter, with the ability to establish priorities
  • Excellent customer service skills, including the ability to assist customers in person and remotely over the phone
  • Familiarity with HIPAA and other regulatory requirements listed above, preferred
  • Prior experience with software in a regulated environment, preferred
  • Exposure to lab or medical business environments and any Lab Information Management System (LIMS), preferred
  • Familiarity with issue tracking software (such as Azure DevOps, Jira or Bugzilla) a plus
  • Ability to work independently and as part of a team
  • Strong attention to detail

    • Education And Experience

  • Associate or bachelor's degree in Information Systems or IT related subject preferred; HS Diploma or GED equivalent with appropriate experience is considered
  • At least 1 year of technical writing experience, required
  • 2+ years of Electronic documentation system / Quality Management System experience, preferred
  • 1+ years of software development lifecycle (SDLC) experience, preferred

    • Compensation

  • Base pay range : $60,000.00 / yr - $67,700.00 / yr
  • Annual Compensation Range $52,700 to $60,200
  • Discretionary Bonus opportunity
  • Comprehensive health coverage : Medical, Dental, and Vision
  • Insurance : Short / Long Term Disability and Life Insurance
  • Financial benefits : 401(k), Flex Spending Account
  • Vacation : 120 hours annually
  • Sick time : 72 hours
  • Holidays : 11 paid holidays + 3 floating holidays
  • Employee Assistance Program
  • Voluntary Benefits
  • Employee recognition program

    • About Us

    Biodesix is a leading diagnostic solutions company, driven to improve clinical care and outcomes for patients. Biodesix Diagnostic Tests support clinical decisions to expedite personalized care and improve outcomes for patients with lung disease. Biodesix Development Services enable the world's leading biopharmaceutical, life sciences, and research institutions with scientific, technological, and operational capabilities that fuel the development of diagnostic tests, tools, and therapeutics. Our Mission : Transform patient care and improve outcomes through personalized diagnostics that are timely, accessible, and address immediate clinical needs. Our Vision : A world where patient diseases are conquered with the guidance of personalized diagnostics. For more information, please visit www.biodesix.com.

    Equal Opportunity

    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.

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