About the role
structured by ORIMore 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.
What you will do
- Overseeing day-to-day activities of the QA team directly supporting manufacturing and quality control operations.
- Provide direct support to the site to ensure compliance with regulatory standards, internal procedures, and quality expectations.
- Provide leadership and guidance to the QA team, driving a culture of continuous improvement, compliance, and operational excellence.
- Perform real-time record review of production records, equipment logbooks, and QC documentation.
- Collaborate across the site to provide real time manufacturing support, supporting issue resolution and documentation.
Full posting text
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 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 Supervisor, Quality Assurance, is responsible for overseeing day-to-day activities of the QA team directly supporting manufacturing and quality control operations. This role provides direct support to the site to ensure compliance with regulatory standards, internal procedures, and quality expectations. The QA Supervisor provides leadership and guidance to the QA team, driving a culture of continuous improvement, compliance, and operational excellence.
The department is responsible for performing real-time record review of production records, equipment logbooks, and QC documentation. Additionally, this department collaborates across the site to provide real time manufacturing support, supporting issue resolution and documentation.
Swing Shift Schedule:
- Monday - Friday, 2:00pm to 10:30pm