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
Physical Demands
Production Associate Roles: Must have visual acuity of 20/20 (corrected or uncorrected) and normal color vision to safely perform critical tasks such as visual inspection of materials, equipment, and labeling, including distinguishing color-coded components in a GMP environment.
Most roles must be able to meet cleanroom gowning requirements, including wearing full gowning (face coverings, gloves, hoods, goggles) for extended periods, as needed. Use of cosmetics (makeup, painted nails), jewelry, or facial piercings is not permitted in the cleanroom, and any skin conditions that cause shedding must be disclosed.
Work Conditions
Many roles must be able to work at either Orca Bio Sacramento location (3400 Business Dr. or 7910 Metro Air Pkwy) based on operational needs, as well as regularly participate in video-based meetings. Also, may be required to work scheduled overtime, weekends, or holidays based on business needs.
Key Responsibilities
Leadership and Team Management:
Minimum Qualifications
Bachelor’s degree in Life Sciences, Chemistry, Biology, or a related scientific discipline
Minimum of 5 years of experience in Quality Assurance within a regulated pharmaceutical, biotechnology, or medical device environment.
Minimum of 1-2 years in a leadership or supervisory role is preferred.
Strong knowledge of cGMP, FDA, and ICH guidelines.
Strong analytical, problem-solving, and decision-making skills.
Excellent written and verbal communication.
Detail-oriented with strong organizational skills.
Ability to manage multiple priorities and work in a fast-paced environment.
