Quality Management System (QMS) Administrator - MasterControl

More than one million people in the United States today are fighting blood cancer. While a traditional allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a late-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks. With our purified, high-precision investigational cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives.

We are seeking a highly motivated and experienced Quality Management System (QMS) Administrator with in-depth expertise in using MasterControl to join our team. This role is integral to maintaining and optimizing the company's quality management processes, ensuring compliance with industry standards and regulations, and supporting continuous improvement initiatives. The QMS Administrator will work closely with cross-functional teams to manage the MasterControl platform, handle document control, change control, audits, metric development, report development and ensure smooth operations within the quality management system.

Key Responsibilities

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

Qualifications

• Experience: Minimum of 3 years of experience in quality management system administration, with at least 2 years of hands-on experience using MasterControl.
• Technical Skills: In-depth knowledge of MasterControl platform, including configuration, workflows, document control, and training modules.
• Certifications: ISO 9001, FDA, GMP, or other relevant quality certifications are a plus.
• Analytical Skills: Strong ability to analyze data and create detailed reports and metrics.
• Attention to Detail: High level of attention to detail and accuracy in managing QMS documentation and workflows.
• Problem Solving: Strong troubleshooting skills, particularly in QMS-related issues within MasterControl.
• Communication Skills: Excellent verbal and written communication skills, with the ability to effectively interact with cross-functional teams.
• Education: Bachelor’s degree in Quality Management, Engineering, Life Sciences, or related field preferred.

Who we are

We are driven by a passion for science and compassion for patients. We act with urgency to ensure our treatments are one day accessible to all who need them.

We live by our core values of passion, courage, and integrity. Excellence in our work means the chance to unlock a better quality of life for our patients, and with that comes tremendous responsibility.

We innovate on a path that hasn’t been paved. We embrace an entrepreneurial spirit and take calculated risks to achieve our mission. We aren’t afraid to ask “why not” and challenge the status quo.

We maintain a start-up culture of camaraderie and leadership by example, regardless of title.

We’re proud to be an equal opportunity employer, and recognize that celebrating our differences creates stronger, lasting solutions that better serve our team, our patients and their healthcare providers.

Notice to staffing firms

Orca Bio does not accept resumes from staffing agencies with which we do not have a written agreement and specific engagement for a particular opening. Our employment activities, inquiries and offers are managed through our HR/Talent team, and all candidates are presented through this channel only. We do not accept unsolicited resumes, and we rarely outsource recruitment.