About the role
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 commercial-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 have built a state-of-the-art, 100,000-square-foot manufacturing facility in Sacramento, CA (7910 Metro Air Pkwy) to ensure the consistent and reliable delivery of our high-precision cell therapy products. This site is essential to advancing our clinical pipeline and supporting future commercial availability of our life-saving therapies. The Specialist, Production Project Support supports the execution and documentation of business process improvements, change controls, CAPA initiatives, and the development and maintenance of Standard Operating Procedures (SOPs). This role works cross-functionally with production, quality assurance, engineering, and continuous improvement teams to ensure timely and compliant execution of changes and improvement projects within a regulated manufacturing environment \n Essential Duties & Key
Responsibilities Assist in the identification, documentation, and implementation of business process improvements to enhance efficiency, quality, and cost-effectiveness. Coordinate data collection and analysis to support root cause investigations and improvement initiatives. Support the preparation, tracking, and execution of change control documentation in compliance with quality and regulatory standards. Ensure all impacted stakeholders are involved in the review and approval of changes. Maintain accurate records of change implementation and outcomes. Support the execution and documentation of corrective and preventive actions, including follow-up activities. Assist in CAPA investigations by compiling data, organizing cross-functional meetings, and tracking completion of action items. Ensure CAPA documentation meets internal and regulatory expectations. Draft, revise, and maintain SOPs in collaboration with subject matter experts. Ensure SOPs reflect current best practices and regulatory
