Specialist I, Quality Assurance

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 Specialist I, Quality Assurance is an integral entry-level role focused on supporting the effective implementation of our quality policies and systems. In this position, you will assist in the management and documentation of quality processes—including deviations, change controls, CAPAs, and document control—and contribute to batch disposition support to ensure products meet our stringent quality standards. Your work directly aids in maintaining regulatory compliance and enhancing our operational excellence, while also providing a foundation for professional growth within a dynamic, fast-paced environment.

Bachelor’s degree in a relevant scientific discipline (e.g., biology, biochemistry, immunology) with 1–3 years of related experience in quality control testing, analytical development, or GMP environments.

Basic understanding of FDA regulations, GMP compliance, and quality system processes.

Exposure to internal audit processes and document control is a plus.

Strong organizational skills, attention to detail, and a commitment to data integrity.

Excellent communication skills and the ability to work both independently and as part of a team in a fast-paced, regulated environment.

Willingness to learn, adapt, and work overtime as necessary, while consistently adhering to cGMP policies and procedures, including proper documentation and use of personal protective equipment.