Technician, Quality Control Environmental Monitoring - 2nd Shift

United States·SacramentoRegular, Full-Time Employeemid

OtherQuality Control

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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,

Technical Tools

OtherQuality Control

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 late-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 investigational cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives.

We operate a dedicated clinical manufacturing facility in Sacramento, CA (3400 Business Drive), which has historically served as the foundation for producing our high-precision cell therapy products. This site plays a critical role in advancing our clinical pipeline and ensuring the consistent, reliable supply of therapies for patients participating in our trials.

The QC Environmental Monitoring Technician is a crucial role in maintaining the integrity and safety of

our cell therapy products, conducting routine and non-routine testing to ensure the environmental

conditions in our cell therapy manufacturing facility meet the highest quality standards.

The incumbent performs testing according to established operating procedures. Conducts routine

environmental monitoring activities in the cell therapy manufacturing facility, including air and surface

monitoring, to ensure compliance with regulatory requirements. Collects samples from critical areas

within the manufacturing facility according to established procedures. Maintains and calibrates

environmental monitoring equipment regularly to ensure accuracy and reliability of measurements.

Maintains accurate and up-to-date records of environmental monitoring activities, including sampling

plans, results, and corrective actions taken. Environmental analyses, including microbial and particulate

matter testing. Performs basic lab functions like reagent preparation.

2nd Shift Hours Worked:

• 1:00pm to 11:30pm

Work Week Schedule:

• Monday through Thursday

Production Associates: 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.

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.

Must be able to work at either Orca Bio Sacramento location (3400 Business Dr. or 7910 Metro Air Pkwy) based on operational needs.

Must be comfortable regularly participating in video-based meetings.

May be required to work scheduled overtime, weekends, or holidays based on business needs.

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 and equipment maintenance

Troubleshoot and address any equipment issues promptly to minimize downtime

Prepare basic and complex reagents as assigned

Order and maintain lab supply inventory

Aliquot samples as required, including aseptic aliquoting

Receive and provide training

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

Collaborate with cross-functional teams, including manufacturing, quality control, and quality assurance, to address environmental monitoring-related issues and implement corrective actions

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

Willingness to work swing and night shifts