Technician, Quality Control Environmental Monitoring
About The Position
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.
Requirements
- 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
- 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.
Responsibilities
- 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
- 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
- Collaborate with cross-functional teams, including manufacturing, quality control, and quality assurance, to address environmental monitoring-related issues and implement corrective actions
Benefits
- You will also be eligible to receive pre-IPO equity, in addition to competitive medical, dental, and vision benefits, PTO, 401(k) plan, life and accidental death and disability coverage, and parental leave benefits.
- Other perks include subsidized daily lunches and snacks at our on-site locations.
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Education Level
No Education Listed
Number of Employees
101-250 employees
