IT QMS Analyst

ABOUT US

OVERVIEW

The 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 systems and 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, 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; H.S. Diploma or GED equivalent with appropriate experience is considered
• 1 to 3 years of documentation or technical writing experience preferably in an electronic documentation system.

COMPENSATION

• Hourly Compensation starting at $25.34
• 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
• 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