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

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

The anticipated annual salary range for this job is based on prior experience in the role/industry, education, location, internal equity, and other job-related factors as permitted by law. For remote-based positions, this range may vary based on your local market. Full-time employment positions will also be eligible to receive pre-IPO equity and annual bonus, in addition to competitive medical, dental, and vision benefits, PTO, 401(k) plan, life and accidental death and disability coverage, and parental leave benefits. Other perks include subsidized daily lunches and snacks at our on-site locations.

Who we are

We are driven by a passion for science and compassion for patients. We act with urgency to ensure our treatments are one day accessible to all who need them.

We live by our core values of passion, courage, and integrity. Excellence in our work means the chance to unlock a better quality of life for our patients, and with that comes tremendous responsibility.

We innovate on a path that hasn’t been paved. We embrace an entrepreneurial spirit and take calculated risks to achieve our mission. We aren’t afraid to ask “why not” and challenge the status quo.

We maintain a start-up culture of camaraderie and leadership by example, regardless of title.

We’re proud to be an equal opportunity employer, and recognize that celebrating our differences creates stronger, lasting solutions that better serve our team, our patients and their healthcare providers.

Notice to staffing firms

Orca Bio does not accept resumes from staffing agencies with which we do not have a written agreement and specific engagement for a particular opening. Our employment activities, inquiries and offers are managed through our HR/Talent team, and all candidates are presented through this channel only. We do not accept unsolicited resumes, and we rarely outsource recruitment.

Technician, Quality Assurance - Night Shift