Technician, Quality Control Environmental Monitoring - 2nd Shift
Sacramento, CA
About the role
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 \n Physical Demands 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. Work Conditions 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. Essential Duties & Key
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 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 Minimum Experience, Education, Certifications, Licenses 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 \n $23 - $26 an hour 2nd shift differential pay of +7% for non-exempt \n The anticipated annual salary range for this job is based on prior experience in
the role/industry, education, location, internal equity, and other job-related factors as permitted by law. For remote-based positions, this range may vary based on your local market. Full-time employment positions will also be eligible to receive pre-IPO equity and annual
bonus, 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.
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, and we rarely outsource recruitment.
