Remote Quality Management Systems Coordinator

Summary

Join our team as a Quality Management Systems (QMS) Coordinator at Care Access, where you will be responsible for managing and improving the QMS within the organization, ensuring its effectiveness and compliance with regulatory standards.

Requirements

• Extensive experience with electronic Quality Management Systems in a highly regulated environment
• Extensive experience of ISO standards and Good Clinical Practice
• Strong Communication and project coordination skills
• Proficient in QMS software platforms and system troubleshooting
• Attention to detail and strong analytical problem solving skills
• Ability to work independently whilst collaborating with cross functional teams
• Proficient in Microsoft Office Suite
• Bachelor's degree in a relevant field or equivalent experience (Life Sciences, Healthcare, or related discipline)

Responsibilities

• Ensure the QMS is kept up-to-date at all times by driving the update for policies, procedures, and templates as required
• Monitor QMS timelines for each QMS module (Documents, Issue Management, CAPA Management)
• Perform systems administration duties such as user management, troubleshooting system issues, and providing technical support to staff
• Regularly monitor the QMS to ensure its effectiveness and compliance with regulatory standards (ISO 9001 and GCP)
• Design, build and modify QMS workflows for processes controlled by the eQMS
• Manage document control activities supporting with the release of documents within the QMS
• Ensure version control of documents, maintaining records of document changes and ensuring outdated versions are appropriately archived
• Coordinate the release of new documents into the QMS, ensuring proper approval processes are followed
• Facilitate communication with staff when new documents or processes are released into the QMS, liaising with the Learning and Development team to ensure training tasks based on role-specific training requirements
• Maintain and update the QMS training matrix
• Provide support and guidance to staff on QMS-related training requirements
• Compile regular reports on the status health and performance of the QMS
• Prepare QMS metrics from the QMS for the Operational Compliance Team

Benefits

• PTO/vacation days, sick days, holidays
• 100% paid medical, dental, and vision Insurance. 75% for dependents
• HSA plan
• Short-term disability, long-term disability, and life Insurance
• 401k retirement plan