Technician, Quality Assurance - Day Shift

Socket.dev; Sacramento (CA); On-site; USD 52,000 - 76,000; Full time

Job summary

Orca Bio in Sacramento is seeking a Technician, Quality Assurance to support production of life-saving cell therapies. The role provides on-the-floor QA oversight, reviews records in real time, and partners with Manufacturing and QC to resolve manufacturing issues in a highly regulated environment.

Reporting to QA leadership, you will ensure adherence to cGMP, maintain documentation accuracy, and help sustain seamless operations across Manufacturing, Quality Control and other Quality functions.

Qualifications

• Adherence to quality standards and regulatory requirements (cGMP).
• Real-time review of production records and documentation.

Responsibilities

• Provide on-the-floor QA oversight to support production of cell therapy products.
• Collaborate with Manufacturing, Quality Control, and other Quality functions to identify and resolve issues and maintain seamless operations.

Job description

Company Overview

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 Technician, Quality Assurance plays a critical role in supporting the production of Orca Bio's life-saving cell therapy products by ensuring adherence to strict quality standards, cGMP compliance, and real-time production support. Reporting into the Quality Assurance leadership team, this position provides on-the-floor QA oversight, conducts real-time record and documentation review, and partners with manufacturing and technical teams to identify and resolve issues. The role collaborates closely with Manufacturing, Quality Control (QC), and other Quality functions to maintain seamless operations in a highly regulated environment.

Day Shift Hours Worked:

• 6:00am to 6:30pm or
• 6:30am to 7:00pm

Work Week Schedule:

• Sunday, Monday, Tuesday + every other Wednesday or
• Thursday, Friday, Saturday + every other Wednesday

Physical Demands

• Production Associate Roles: Must have visual acuity of 20/20 (corrected or uncorrected) and normal color vision to safely perform critical tasks such as visual inspection of materials, equipment, and labeling, including distinguishing color-coded components in a GMP environment.
• Most roles must be able to meet cleanroom gowning requirements, including wearing full gowning (face coverings, gloves, hoods, goggles) for extended periods, as needed. Use of cosmetics (makeup, painted nails), jewelry, or facial piercings is not permitted in the cleanroom, and any skin conditions that cause shedding must be disclosed.

Work Conditions

• Many roles must be able to work at