Quality Management System Administrator

Summary

Join Orca Bio, a late-stage biotechnology company revolutionizing blood cancer treatment, as a Quality Management System (QMS) Administrator. This crucial role involves managing and optimizing the company's MasterControl QMS platform, ensuring compliance with industry standards, and supporting continuous improvement initiatives. You will oversee document control, provide training, prepare for audits, troubleshoot system issues, and collaborate with cross-functional teams. The ideal candidate possesses at least 3 years of QMS administration experience, including 2 years with MasterControl, and strong analytical and communication skills. A Bachelor's degree in a related field is preferred. This position offers the opportunity to contribute significantly to improving patient lives while working in a dynamic and innovative environment.

Requirements

• Minimum of 3 years of experience in quality management system administration, with at least 2 years of hands-on experience using MasterControl
• In-depth knowledge of MasterControl platform, including configuration, workflows, document control, and training modules
• Strong ability to analyze data and create detailed reports and metrics
• High level of attention to detail and accuracy in managing QMS documentation and workflows
• Strong troubleshooting skills, particularly in QMS-related issues within MasterControl
• Excellent verbal and written communication skills, with the ability to effectively interact with cross-functional teams

Responsibilities

• Manage, maintain, and optimize the MasterControl QMS platform to support quality processes across the organization. This includes configuring user access, workflows, and system settings
• Oversee document management processes within MasterControl, ensuring that all documents are accurately categorized, reviewed, approved, and updated in compliance with regulatory standards
• Provide training to employees on MasterControl and QMS best practices. Support the onboarding process for new team members and ensure they understand the system’s functionalities
• Ensure adherence to regulatory standards (such as ISO 9001, FDA, or GMP) and internal policies by managing and monitoring the QMS activities through MasterControl
• Prepare for and assist during internal and external audits. Ensure MasterControl records are accurate, up-to-date, and ready for audit reviews
• Act as the go-to point of contact for troubleshooting MasterControl issues, collaborating with the IT team or MasterControl support when necessary
• Identify opportunities to streamline and improve QMS processes within MasterControl. Suggest and implement process improvements to enhance overall system effectiveness
• Generate and analyze reports from MasterControl to monitor the performance of the QMS and provide insights to senior management on key metrics
• Work with various departments (e.g., R&D, Operations, Regulatory, and Compliance) to ensure QMS processes are aligned with organizational goals and standards
• Manage change control processes within MasterControl, ensuring that changes to systems, processes, or documents are well-documented, approved, and implemented according to established protocols

Preferred Qualifications

• ISO 9001, FDA, GMP, or other relevant quality certifications are a plus
• Bachelor’s degree in Quality Management, Engineering, Life Sciences, or related field preferred