Specialist, Quality Assurance

Contractor/Consultant – Quality Assurance

Location:

Sacramento, CA

Engagement Type:
Contract / Consultant

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 versus host disease. Orca Bio is a late‑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 investigational cell therapies we hope to not only replace patients’ blood and immune systems with healthy ones, but also restore their lives.

We operate a dedicated clinical manufacturing facility in Sacramento, CA (3400 Business Drive), which has historically served as the foundation for producing our high‑precision cell therapy products. This site plays a critical role in advancing our clinical pipeline and ensuring the consistent, reliable supply of therapies for patients participating in our trials.

• Approximately 6 months (July-December)

• 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.
• 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.

• Must be able to work at either Orca Bio Sacramento location (3400 Business Dr. or 7910 Metro Air Pkwy) based on operational needs.
• Must be comfortable regularly participating in video‑based meetings.
• May be required to work scheduled overtime, weekends, or holidays based on business needs.

• Oversee the management of quality systems including deviations, change controls, CAPAs, and document control.
• Ensure that all deviations are investigated thoroughly and timely, identifying root causes and implementing effective corrective actions.
• Review and approve change controls to ensure compliance with regulatory requirements and internal procedures.
• Maintain and improve CAPA processes to ensure effective resolution of quality issues.

• Evaluate batch records and associated documentation to make informed batch release decisions.
• Collaborate with manufacturing and quality control teams to ensure all products meet regulatory and quality standards before release.
• Monitor and document any quality issues related to batch production and implement corrective measures as necessary.

• Maintain the document management system to ensure all quality‑related documents are accurate, current, and compliant with regulatory standards.
• Conduct regular reviews of quality documentation to ensure adherence to established protocols and procedures.

• Stay informed of current regulations, industry trends, and best practices in pharmaceutical quality assurance.
• Assist in preparing for internal and external audits, ensuring that all quality systems and documentation are audit‑ready.

• Provide training and guidance to staff on quality systems, processes, and compliance requirements.
• Serve as a point of contact for quality‑related inquiries and issues, fostering a culture of quality within the organization.

• Participate in continuous improvement initiatives to enhance the effectiveness and efficiency of quality systems and processes.
• Identify areas for improvement within quality operations and suggest appropriate solutions.
• Track completion of quality records and maintain metrics.
• Perform other duties as requested by supervisor/manager to support Quality.
• Work collaboratively with cross‑functional teams, including manufacturing, research and development, and…