Supervisor, Quality Control

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 Supervisor, Quality Control (QC) oversees daily operations within the QC laboratory to ensure compliance with regulatory standards, internal procedures, and quality expectations. This position plays a critical role in maintaining data integrity through audit trail reviews, leading investigations of out‑of‑specification (OOS) results and deviations, and ensuring the lab remains in a consistent state of inspection readiness.

• Day Shift: 6:00am to 6:30pm or 6:30am to 7:00pm
• Night Shift: 6:00pm to 6:30am or 6:30pm to 7:00am
• Work Week
  
  Schedule:
  
  Sunday, Monday, Tuesday + every other Wednesday or Thursday, Friday, Saturday + every other Wednesday

• 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, 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. They may also be required to work scheduled overtime, weekends, or holidays based on business needs.
• Lab work and supervisor roles:
  Lead routine quality control testing on raw materials, process intermediates, and final cell therapy products. Supervise the QC team, supporting data verification, leading investigations, prioritizing tasks, and collaborating with other teams. Perform tests, ensure compliance, maintain the lab, prepare reagents, aliquot samples, assist with assay transfer/validation, train staff, and manage supplies.
• Data Integrity and Audit Trail Review:
  Ensure GMP compliance by conducting audit trail reviews, identifying data integrity issues, and ensuring proper documentation.
• Investigations and CAPA:
  Oversee Quality System investigations into OOS results, atypical findings, and lab deviations. Ensure root cause analysis, documentation, and implementation of CAPAs, collaborating with cross‑functional teams to resolve quality issues.
• Lab Inspection Readiness:
  Monitor lab conditions to ensure compliance with cGMP and FDA/EMA regulations, maintaining documentation, equipment logs, and records for inspection readiness. Lead preparation activities for internal and external audits, including document reviews and mock audits.
• Team Leadership and Oversight:
  Manage and support a team of QC analysts, overseeing scheduling, training, and performance evaluations. Provide technical guidance and mentorship to ensure high‑quality, compliant practices.
• Documentation and Reporting:
  Review and approve analytical data, protocols, and reports for accuracy and compliance. Maintain metrics for lab performance, deviations, investigations, and audit trail reviews.
• Identify…