Specialist I, Quality Assurance

orcabiosystems; Sacramento (CA); On-site; USD 95,000 - 140,000; Full time

Benefits offered by this job

Pre-IPO equity

Annual bonus

Medical, dental, and vision benefits

PTO

401(k) plan

Life and disability coverage

Parental leave

Subsidized lunches

Job summary

Orca Bio, a Sacramento-based biotechnology company, seeks a Specialist in Quality Assurance to manage quality systems, deviations, CAPA, change control, and document management. You will ensure batch dispositions meet quality standards before release and support fast processing times for innovative cell therapies.

Join a culture focused on science and patient outcomes, with on-site benefits, competitive compensation, and equity opportunities in a fast-growing company.

Qualifications

• Experience managing quality systems including deviations, CAPA, change control, and document management.

Responsibilities

• Manage quality systems, including deviations, change controls, CAPA, and document management.
• Make timely batch disposition decisions to ensure product quality before release.
• Support rapid processing times required by our next‑generation cell therapies.

Skills

Quality Assurance

CAPA

Document management

Deviation handling

Change control

Job description

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.

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 Specialist, Quality Assurance position is a key role in meeting the quality policy through their management of the different quality systems, including production records and deviation system management. The ideal candidate will be responsible for managing the quality systems, including deviations, change control, corrective and preventive actions (CAPA), and document management. Additionally, this role involves making timely batch disposition decisions to ensure quality standards are met before product release, supporting the rapid processing times required by our product. You will have the unique opportunity to make a difference in the lives of many patients as Orca Bio develops next‑generation cell therapies.

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.

• 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 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.