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 QA Specialist II supports the quality management system (QMS) through performing raw material release activities, acting as a system administrator for the document management system, establishing & executing QMS procedures, and internal auditing.

·       Perform routine inspection and release of raw materials

·       Support batch record release activities

·       Support review of logbooks, procedures and protocols

·       Act as a system administrator for master control as back-up support

·       Perform review of quality records such as deviations, change controls and CAPAs

·       Track completion of quality records and maintain metrics.

·       Receive and provide training

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

·       Work collaboratively with cross-functional teams, including manufacturing, research and development, and quality assurance, to support the overall quality of cell therapy products

·       Communicate effectively with team members and contribute to a positive and collaborative work environment

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

·       Strong organizational skills and the ability to manage multiple tasks concurrently

·       Willingness to learn and adapt in a fast-paced, dynamic environment

·       Adhere to cGMP policies and procedures, including documentation activities

·       Willingness to work overtime as required

·       Able to wear appropriate personal protective equipment

·       Bachelor’s degree in a relevant scientific discipline (biology, biochemistry, immunology, etc.) with 5+ years of experience in quality control testing, analytical development, or GMP; OR a Master’s degree in relevant scientific disciplines with 3+ years of experience

·       Moderate understanding of quality systems processes

·       Experience in quality control or GMP within a cell therapy or biopharmaceutical manufacturing environment is preferred, including raw material release

·       Able to meet project and testing timelines

·       Detail-oriented with a commitment to data integrity and accuracy, and an ability to identify problems with data management

·       Able to work collaboratively to respond to changing priorities and challenges

·       Ability to work both independently and collaboratively with a multi-disciplinary team in a fast-paced and regulated environment

· Prior experience doing internal audits and document control management

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.

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.