Specialist I, Quality Assurance

Job description

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. ### Physical Demands & Work Conditions - *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. - *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. ### Responsibilities **Quality System Support:** - Assist in managing quality systems such as deviations, change controls, CAPAs, and document control. - Support thorough and timely investigations of deviations and assist in documenting root cause analyses and corrective actions. - Help review and document change controls in compliance with regulatory requirements and internal procedures. **Batch Disposition Support:** - Support the review of batch records and related documentation, assisting in the evaluation of batch release data. - Collaborate with manufacturing and quality control teams to document and address any quality issues during batch processing. **Document Management & Regulatory Support:** - Assist in maintaining the document management system, ensuring accuracy and compliance with regulatory standards. - Help prepare quality documentation for internal and external audits and support adherence to cGMP protocols. **Training, Collaboration, and Continuous Improvement**: - Provide basic training and support to staff on quality systems and procedures. - Collaborate with cross-functional teams, including manufacturing and research & development, to assist in quality improvement initiatives. - Participate in continuous improvement efforts and track the progress of quality-related activities. ### General Requirements - 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.