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Orca Bio

Posted 2 months ago

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Technician, Quality Control - 1st Shift

SacramentoOn-siteFull-time

AI Summary

Performs routine to moderately complex analytical tests in a GMP cell therapy QC lab, ensuring data integrity and equipment readiness to support the company’s clinical manufacturing.

About this role

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 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.

The Technician, Quality Control conducts routine and non-routine testing to ensure the highest quality standards in our cell therapy manufacturing facility. Your work will play a crucial role in maintaining the integrity and safety of our cell therapy products.
1st Shift Hours Worked:
• 7:00am to 3:30pm
Work Week Schedule:
• Monday through Friday

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.

    • 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.
  • 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.

    • Job Duties & Key Responsibilities

  • Perform a range of basic to moderately complex analytical tests following cGMP guidelines
  • Test routine and non-routine samples; document results with accuracy and compliance
  • Maintain, calibrate, and troubleshoot lab equipment to ensure functionality
  • Prepare reagents and aliquot samples, including aseptic techniques when needed
  • Monitor and maintain inventory of lab supplies
  • Support assay transfers, validations, and equipment qualifications
  • Aliquot samples as required, including aseptic aliquoting
  • Actively participate in group and project teamwork; project and process improvements
  • Work cross-functionally with Manufacturing, QC, and QA to resolve issues and implement corrective actions
  • Follow all cGMP documentation and procedural standards
  • Perform additional duties as assigned to support the Quality team

    • Minimum Qualifications

  • A.S. or B.S. in a relevant scientific discipline (biology, microbiology, etc.) required
  • High attention to detail and a commitment to data integrity
  • Strong organizational, communication, and problem-solving skills
  • Ability to work both independently and collaboratively in a fast-paced, regulated setting
  • Flexible and responsive to changing priorities and team needs
  • Preferred: Experience with analytical assays (e.g., flow cytometry, ELISA, PCR)
  • Preferred: Familiarity with aseptic technique in a GMP or biotech setting

    • Skills

    Aseptic Sample HandlingAseptic TechniqueAssay Transfers And ValidationsCalibration/troubleshooting Of Lab EquipmentCGMP DocumentationData Entry And/ Or LIMS Or Similar SystemsDocumentation StandardsELISAFlow CytometryGMP/ISO Cleanroom PracticesInventory ManagementLaboratory SafetyPCRQA/QC CollaborationReagent PreparationSample ProcessingStatistical Data AnalysisSterile TechniqueTroubleshooting Analytical Instruments

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