Technician, Quality Assurance - Day Shift

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 commercial-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 cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives.

About the role

This position 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 role 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.

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

Requirements

• 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
• 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
• Ability to work at either Orca Bio Sacramento location (3400 Business Dr. or 7910 Metro Air Pkwy) based on operational needs
• Regularly participate in video-based meetings
• May be required to work scheduled overtime, weekends, or holidays based on business needs

Qualifications

• Coursework or experience in a scientific discipline (e.g., biology, microbiology, environmental science), including A.S. or B.S. degree (preferred)
• Prior experience in a regulated environment (e.g., GMP, biopharma, or cell therapy manufacturing) (preferred)
• Understanding of aseptic technique, environmental monitoring, and microbiology principles (preferred)
• 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 (preferred)

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

Pay

Base hourly pay range: $24–$26. Annualized earnings reflect estimated scheduled overtime. There is no shift differential for day shift. Total compensation will vary based on assigned shift, overtime worked, and applicable differentials. The anticipated annual salary range for this job is $61,152 - $66,248, based on prior experience in the role/industry, education, location, internal equity, and other job-related factors as permitted by law.

Schedule

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

Benefits

• Pre-IPO equity and annual bonus
• Competitive medical, dental, and vision benefits
• PTO
• 401(k) plan
• Life and accidental death and disability coverage
• Parental leave benefits
• Subsidized daily lunches and snacks at on-site locations

About Us

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.