Sr. Specialist, Quality Assurance

Overview

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 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 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 Sr. Specialist, Quality Assurance is a key role in meeting the quality policy through their management of the different quality systems, including production records and deviation system management. The Sr. Specialist will support complex problem-solving initiatives and help drive continuous improvement at the site. This position is expected to coach / develop site personnel and improve overall execution within the quality systems.

The ideal candidate will be responsible for managing the quality systems, including deviations, change control, corrective and preventive actions (CAPA), validation, and document management. Additionally, this role involves making timely batch disposition decisions to ensure quality standards are met before product release, supporting the rapid processing times required by our product. You will have the unique opportunity to make a difference in the lives of many patients as Orca Bio develops next-generation cell therapies.

Physical Demands

• Production Associates:
  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.

Work Conditions

• 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.

Essential Duties &

Key Responsibilities:

• Quality System Management:
• Oversee the management of quality systems including deviations, change controls, CAPAs, validation, and document control.
• Provide clear direction, support, and/or coaching to site personnel, improving the overall performance and/or execution in the quality systems.
• Directly support the Process Validation program, including the Continuous Process Verification (CPV) program. Directly support investigations of any identified trend.
• 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.

• Batch Disposition:
• 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.

• Document Management:
• 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.

• Regulatory Compliance:
• 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.

• Training and Support:
• Develop / coach site personnel to improve overall performance in quality systems.
• 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.

• Continuous Improvement:
• Lead continuous improvement…