Quality Assurance Technician

Over one million people in the world today are fighting blood cancer. While a traditional allogeneic stem cell transplant has been the best hope for many patients, the transplant itself can prove fatal or lead to serious conditions, such as graft versus host disease.

Orca Bio's investigational, high-precision cell therapies are designed to replace a patient's compromised blood and immune system with a healthy one, while dramatically lowering the risk of developing life-threatening or debilitating transplant-related side-effects. The first application of Orca Bio's platform is in blood cancer where the unmet need is most acute; with a robust pipeline of promising cell therapies, we plan to extend into autoimmune diseases and genetic blood disorders as well.

The Quality Assurance Technician will help to establish on the floor quality assurance activities. In this role, you will review logbooks and QC documentation as well as act as a document control system administrator as needed. You will have the unique opportunity to make a difference in the lives of many patients ensuring that we deliver high quality products right - the first time. You will work out of our new manufacturing facility in Sacramento, CA.

Specific Responsibilities

• Perform a broad variety of basic and moderate complex tests in support of quality assurance activities

• Review routine and non-routine documents according to cGMP

• Troubleshoot and address any equipment with production promptly to minimize downtime.

• Receive and provide training

• Perform other duties as requested by supervisor/manager to support Quality

• Collaborate with cross-functional teams, including manufacturing, quality control, and quality assurance, to address environmental monitoring-related issues and implement corrective actions

Requirements

• Receive and provide training

• Identify and support resolution of technical problems

• Actively participate in group and project teamwork; project and process improvements

• Resolve issues as needed with management approval

• Adhere to cGMP policies and procedures, including documentation activities

• Perform other duties as requested by supervisor/manager to support Quality

Desired Experience

• Classes in a relevant scientific discipline (biology, microbiology, environmental science, etc.)

• Excellent organizational, communication, and problem-solving skills

• Detail-oriented with a strong commitment to data integrity and accuracy

• Ability to work independently and as part of a team in a fast-paced and regulated environment

• Adaptable and responsive to changing priorities and challenges

• No experience is required, but experience in microbiology, environmental monitoring, aseptic technique, or GMP within a cell therapy or biopharmaceutical manufacturing environment is a plus

The anticipated hourly pay for this non-exempt, U.S. based job is $26-$34. The final offer will be based on professional experience previously in this role/industry, education, geographic location, internal equity, and other job-related factors as permitted by law. For remote-based candidates, this range may vary based on your local market. Actual compensation may vary. You will also be eligible to receive pre-IPO equity, in addition to medical, dental, vision, PTO, 401(k) plan, life and accidental death and disability coverage, and parental leave benefits. Total compensation will be determined at the Company's sole discretion.

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 patients who need them.

We strive to do things right, and to embody our core values of passion, courage, and integrity. Excellence in our work means the potential to unlock a better quality of life for our patients, and with that comes tremendous responsibility.

We innovate daily on a path that hasn't been paved. This means we lean heavily on our entrepreneurial spirit and are comfortable taking calculated risks to achieve progress toward our mission. It means we aren't afraid to ask "why not," and encourage lively discourse around rethinking the status quo.

We work hard to preserve our start-up culture rooted in camaraderie and leadership by example - by everyone, regardless of title.

We're proud to be an equal opportunity employer, and have seen how our differences - when celebrated and woven together - create stronger and more lasting solutions that better serve our team, our partners, and most importantly, our patients and the providers who treat them.

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 department, and all candidates are presented through this channel only. We do not accept unsolicited resumes.