Quality Control Associate
Sacramento, CA, USA
Posted on Friday, April 7, 2023
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.
Conducts routine and non-routine analysis, but not limited to biochemical and chemical analysis of processes leading up to drug product according to established operating procedures. Compiles data for documentation of test procedures. Calibrates and maintains lab and analytical equipment. Participates in the preparation of investigations, summaries and reports. Reviews data obtained for compliance to specifications and reports abnormalities. Revises and updates standard operating procedures as needed. May perform special projects
on analytical and instrument problem solving.
- Perform a broad variety of basic and moderate complex tests in support of lab operations
- Perform testing of routine and non-routine samples and documents according to cGMP
- Perform routine lab maintenance
- Prepare basic and complex reagents as assigned
- Order and maintain lab supply inventory
- Aliquot samples as required, including aseptic aliquoting
- Receive and provide training
- Participate in assay transfer and assay validation
- Perform equipment qualification/maintenance
- 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
- B.S./B.A degree (preferably in Microbiology or similar field) or an equivalent combination of education and experience.
- Basic knowledge of scientific theories, principles, and techniques used in analytical or biological test procedures.
- Ability to exercise sound judgement, reasoning, and problem solving.
- Capable of completing assigned responsibilities and keeping manager informed of status.
- Experience with directly applicable laboratory equipment and techniques; can apply knowledge and technical understanding to complete routine and non-routine assignments.
- Good verbal and written communication skills needed to accomplish assigned tasks.
Who we are
We are scientists, engineers and business operators working with urgency to develop new therapies for patients faced with no or extremely limited options today.
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. 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.
We invite you to join us and bring your unique perspective and experiences to our team.
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