Description:

Orca Bio is a late-stage biotechnology company focused on redefining the transplant process through next-generation cell therapies.
The company is seeking a Quality Management System (QMS) Administrator with expertise in MasterControl to maintain and optimize quality management processes.
The QMS Administrator will ensure compliance with industry standards and support continuous improvement initiatives.
Key responsibilities include managing the MasterControl platform, overseeing document control, providing training, ensuring compliance, preparing for audits, troubleshooting system issues, identifying process improvements, generating reports, collaborating with cross-functional teams, and managing change control processes.

Requirements:

A minimum of 3 years of experience in quality management system administration, with at least 2 years of hands-on experience using MasterControl is required.
In-depth knowledge of the MasterControl platform, including configuration, workflows, document control, and training modules is essential.
Relevant quality certifications such as ISO 9001, FDA, or GMP are a plus.
Strong analytical skills to analyze data and create detailed reports and metrics are necessary.
A high level of attention to detail and accuracy in managing QMS documentation and workflows is required.
Strong troubleshooting skills, particularly in QMS-related issues within MasterControl, are needed.
Excellent verbal and written communication skills are essential for effective interaction with cross-functional teams.
A Bachelor’s degree in Quality Management, Engineering, Life Sciences, or a related field is preferred.

Orca Bio offers a dynamic work environment driven by a passion for science and compassion for patients.
The company promotes a culture of camaraderie and leadership by example, regardless of title.
Employees are encouraged to embrace an entrepreneurial spirit and take calculated risks to achieve the company's mission.
Orca Bio is an equal opportunity employer, celebrating diversity to create stronger solutions for the team and patients.