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Quality Assurance Specialist II

Orca Bio

Orca Bio

Quality Assurance
Sacramento, CA, USA
Posted on Friday, February 23, 2024
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 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 investigational cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives.
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.
Specific Responsibilities
· 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
General Requirements
· 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
Desired Experience
· 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
The anticipated annual salary for this U.S. based job is $75,000– $105,000. 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 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.