Quality Control Environmental Monitoring Lab Technician

Over one million people in the world today are fighting blood cancer. While a traditional allogeneic stem cell transplant has been the best hope for many patients, the transplant itself can prove fatal or lead to serious conditions, such as graft versus host disease.

Orca Bio's investigational, high-precision cell therapies are designed to replace a patient's compromised blood and immune system with a healthy one, while dramatically lowering the risk of developing life-threatening or debilitating transplant-related side-effects. The first application of Orca Bio’s platform is in blood cancer where the unmet need is most acute; with a robust pipeline of promising cell therapies, we plan to extend into autoimmune diseases and genetic blood disorders as well.

The QC Environmental Monitoring Technician conducts routine and non-routine testing to ensure the environmental conditions in our cell therapy manufacturing facility meet the highest quality standards. Your work will play a crucial role in maintaining the integrity and safety of our cell therapy products.

The EM Technician 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.

Specific 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

Requirements

·       Perform a broad variety of basic and moderately complex tests in support of lab operations

·       Perform testing of routine and non-routine samples and documents according to cGMP

·       Perform routine lab maintenance

·       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

Desired Experience

·       Classes in a relevant scientific discipline (biology, microbiology, environmental science, etc.), degree a plus

·       Excellent organizational, communication, and problem-solving skills

·       Detail-oriented with a strong commitment to data integrity and accuracy

·       Ability to work independently and as part of a team in a fast-paced and regulated environment

·       Adaptable and responsive to changing priorities and challenges

·       No experience is required, but experience in microbiology, environmental monitoring, aseptic technique, or GMP within a cell therapy or biopharmaceutical manufacturing environment is a plus

The anticipated hourly pay for this non-exempt, U.S. based job is $26–$34. The final offer will be based on professional experience previously in this role/industry, education, geographic location, internal equity, and other job-related factors as permitted by law. For remote-based candidates, this range may vary based on your local market. Actual compensation may vary. You will also be eligible to receive pre-IPO equity, in addition to medical, dental, vision, PTO, 401(k) plan, life and accidental death and disability coverage, and parental leave benefits. Total compensation will be determined at the Company's sole discretion. 

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 patients who need them.

We strive to do things right, and to embody our core values of passion, courage, and integrity. Excellence in our work means the potential to unlock a better quality of life for our patients, and with that comes tremendous responsibility.

We innovate daily on a path that hasn’t been paved. This means we lean heavily on our entrepreneurial spirit and are comfortable taking calculated risks to achieve progress toward our mission. It means we aren’t afraid to ask “why not,” and encourage lively discourse around rethinking the status quo.

We work hard to preserve our start-up culture rooted in camaraderie and leadership by example - by everyone, regardless of title.

We’re proud to be an equal opportunity employer, and have seen how our differences - when celebrated and woven together - create stronger and more lasting solutions that better serve our team, our partners, and most importantly, our patients and the providers who treat them.

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 department, and all candidates are presented through this channel only. We do not accept unsolicited resumes.

Salary : $26 - $34