The Role
Supports quality assurance systems in a regulated cell therapy manufacturing environment. Responsibilities include managing deviations, change controls, CAPAs, and document control; reviewing batch records and release data; supporting investigations, audits, cGMP compliance, staff training, and continuous improvement initiatives. Collaborates with manufacturing, quality control, and R&D teams while maintaining data integrity and accurate quality documentation.
Summary Generated by Built In
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
- 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.
Responsibilities
- 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.
- 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.
- 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.
- 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.
Quality System Support:
Batch Disposition Support:
Document Management & Regulatory Support:
Training, Collaboration, and Continuous Improvement:
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.
The anticipated annual salary range (listed above) for this job is based on prior experience in the role/industry, education, location, internal equity, and other job-related factors as permitted by law. For remote-based positions, this range may vary based on your local market. Full-time employment positions will also be eligible to receive pre-IPO equity and annual bonus, in addition to competitive medical, dental, and vision benefits, PTO, 401(k) plan, life and accidental death and disability coverage, and parental leave benefits. Other perks include subsidized daily lunches and snacks at our on-site locations.
Who we are
We are driven by a passion for science and compassion for patients. We act with urgency to ensure our treatments are one day accessible to all who need them.
We live by our core values of passion, courage, and integrity. Excellence in our work means the chance to unlock a better quality of life for our patients, and with that comes tremendous responsibility.
We innovate on a path that hasn’t been paved. We embrace an entrepreneurial spirit and take calculated risks to achieve our mission. We aren’t afraid to ask “why not” and challenge the status quo.
We maintain a start-up culture of camaraderie and leadership by example, regardless of title.
We’re proud to be an equal opportunity employer, and recognize that celebrating our differences creates stronger, lasting solutions that better serve our team, our patients and their healthcare providers.
Notice to staffing firms
Orca Bio does not accept resumes from staffing agencies with which we do not have a written agreement and specific engagement for a particular opening. Our employment activities, inquiries and offers are managed through our HR/Talent team, and all candidates are presented through this channel only. We do not accept unsolicited resumes, and we rarely outsource recruitment.
Skills Required
- Bachelor's degree in a relevant scientific discipline such as biology, biochemistry, or immunology
- 1-3 years of related experience in quality control testing, analytical development, or GMP environments
- Basic understanding of FDA regulations
- Basic understanding of GMP compliance and quality system processes
- Strong organizational skills and attention to detail
- Commitment to data integrity
- Excellent communication skills
- Ability to work independently and as part of a team in a fast-paced, regulated environment
- Willingness to learn, adapt, and work overtime as necessary
- Adherence to cGMP policies and procedures, including proper documentation and use of personal protective equipment
- Exposure to internal audit processes and document control
- Ability to meet cleanroom gowning requirements
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The Company
What We Do
Orca Bio is a clinical-stage biotechnology company developing a pipeline of high precision allogeneic cell therapy products that are designed to safely replace patients’ diseased blood and immune system with a healthy one. Our manufacturing platform sorts donor blood with single-cell precision and a high level of purity and speed, enabling us to create proprietary, optimal therapeutic mixtures of immune and stem cells that have the potential to transform allogeneic cell therapy. Our talented team is driven by a passion for science and compassion for patients.
