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Orca Bio

Posted 3 months ago

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Technician, Quality Assurance - Night Shift

SacramentoOn-siteFull-time

AI Summary

QA-focused technician role supporting real-time review of production records in a GMP cell therapy environment, ensuring documentation, CAPA, and deviation resolution aligned with QA processes.

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 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 Technician, Quality Assurance plays a critical role in supporting the production of Orca Bio’s life-saving cell therapy products by ensuring adherence to strict quality standards, cGMP compliance, and real-time production support. Reporting into the Quality Assurance leadership team, this position provides on-the-floor QA oversight, conducts real-time record and documentation review, and partners with manufacturing and technical teams to identify and resolve issues. The role collaborates closely with Manufacturing, Quality Control (QC), and other Quality functions to maintain seamless operations in a highly regulated environment.

Night Shift Hours Worked:

• 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

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.

    • Key Responsibilities

  • Perform real-time review of production records, equipment logbooks, and QC documentation to ensure compliance with good documentation practices and cGMP requirements
  • Partner with manufacturing and technical staff to review records and ensure product quality rationale supports batch disposition decisions
  • Support real-time troubleshooting of equipment or production issues to minimize downtime and ensure uninterrupted manufacturing
  • Conduct routine walkthroughs of classified areas (manufacturing and warehouse) to verify compliance with cGMP standards
  • Escalate significant issues to QA and operational leadership as appropriate
  • Provide coaching, training, and guidance to internal teams regarding compliance, documentation, and best practices
  • Collaborate cross-functionally to address deviations and implement corrective and preventive actions (CAPA)
  • Support broader QA functions as needed, including document control and deviation management
  • Participate in continuous improvement efforts to enhance quality systems, efficiency, and compliance

    • Minimum Qualifications

    • Ability to wear cleanroom gowning and adhere to cleanroom entry and gowning requirements
    • Demonstrated ability to identify and support resolution of technical issues
    • Familiarity with cGMP regulations and documentation practices
    • Proven experience collaborating in cross-functional or project teams
    • Strong attention to detail and ability to follow QA processes and escalation pathways

    Preferred Qualifications

  • Coursework or experience in a scientific discipline (e.g., biology, microbiology, environmental science), including A.S. or B.S. degree
  • Prior experience in a regulated environment (e.g., GMP, biopharma, or cell therapy manufacturing)
  • Understanding of aseptic technique, environmental monitoring, and microbiology principles
  • Strong organizational, communication, and problem-solving skills
  • Ability to adapt quickly in a dynamic, fast-paced environment and manage shifting priorities
  • Experience contributing to investigations, CAPAs, or other QA system elements

    • Personal Qualities

  • Highly detail-oriented with strong commitment to data integrity and documentation accuracy
  • Collaborative mindset with strong interpersonal and communication skills
  • Willingness to take initiative and provide support beyond defined responsibilities
  • Adaptable, dependable, and motivated by Orca Bio’s mission to serve patients

    • Skills

    Batch DispositionCAPACGMPCross-Functional CollaborationDeviation ManagementDocument ControlElectronic Documentation SystemsEnvironmental ControlEnvironmental MonitoringEquipment LogbooksGowning And Cleanroom ProceduresInvestigationsMicrobiology PrinciplesProduction RecordsQA DocumentationQuality SystemsRecord ReviewTraining And CoachingTroubleshooting

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