Is the Specialist I, Quality Assurance role remote?

No — this is an on-site role in Sacramento, CA.

Where is the role based?

Orca Bio is hiring for this position in Sacramento, CA.

What seniority level is this role?

Orca Bio targets mid-level candidates for this position.

Is this full-time or contract?

Full-time for this Specialist I, Quality Assurance role at Orca Bio.

Specialist I, Quality Assurance at Orca Bio

Joblaze summary

In the Specialist I, Quality Assurance role at Orca Bio, the individual is tasked with overseeing various quality systems, including managing production records and handling deviations. Proficiency in quality assurance processes such as change control and CAPA is essential, along with the ability to make timely decisions regarding batch disposition. This position is well-suited for someone with a solid background in quality assurance within the biotechnology sector, particularly at a commercial stage company focused on innovative therapies. The role offers a chance to contribute significantly to the development of life-saving treatments for patients battling blood cancer.

Joblaze insights

Listed 10 days ago on Joblaze — tracked directly from Orca Bio's career page.
Orca Bio has 53 other open roles including Clinical Research Associate, General Manager, Commercial Manufacturing Facility, Director/Head, Pharmacovigilance.

Quick facts

Is the Specialist I, Quality Assurance role remote?: No — this is an on-site role in Sacramento, CA.
Where is the role based?: Orca Bio is hiring for this position in Sacramento, CA.
What seniority level is this role?: Orca Bio targets mid-level candidates for this position.
Is this full-time or contract?: Full-time for this Specialist I, Quality Assurance role at Orca Bio.

From the original posting

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.

Specialist I, Quality Assurance

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