Technician, Lab Systems and Equipment

Orca Bio•Sacramento, CA

12d•$23 - $29•Hybrid

About The Position

Orca Bio is a commercial-stage biotechnology company focused on redefining the transplant process with next-generation cell therapies to improve survival rates and reduce risks associated with blood cancer treatments. The company has established a state-of-the-art manufacturing facility in Sacramento, CA. The Technician, Quality Assurance plays a crucial role in supporting the production of Orca Bio’s cell therapy products by ensuring adherence to strict quality standards, cGMP compliance, and providing real-time production support. This position involves on-the-floor QA oversight, review of records and documentation, and collaboration with manufacturing and technical teams to resolve issues. The role works closely with Manufacturing, Quality Control (QC), and other Quality functions to maintain operations in a highly regulated environment.

Requirements

Ability to work a consistent 1st shift schedule (Monday–Friday, 7:00am - 3:30pm)
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
Must have visual acuity of 20/20 (corrected or uncorrected) and normal color vision
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 remain in a stationary position while reviewing records or working in a cleanroom environment
Must comply with gowning requirements (no cosmetics, jewelry, etc.) and disclose any shedding skin conditions
May need to ascend/descend stairs and walk through classified spaces during routine walkthroughs

Nice To Haves

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

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