Fda Biologist Jobs in Arizona (NOW HIRING)

At Caris, we understand that cancer is an ugly word - a word no one wants to hear, but one that connects us all. That's why we're not just transforming cancer care - we're changing lives. We introduced precision medicine to the world and built an industry around the idea that every patient deserves answers as unique as their DNA. Backed by cutting-edge molecular science and AI, we ask ourselves every day: "What would I do if this patient were my mom?" That question drives everything we do. But our mission doesn't stop with cancer. We're pushing the frontiers of medicine and leading a revolution in healthcare - driven by innovation, compassion, and purpose. Join us in our mission to improve the human condition across multiple diseases. If you're passionate about meaningful work and want to be part of something bigger than yourself, Caris is where your impact begins.

The Supervisor - Reagent QC Molecular Operations is responsible for overseeing the daily operations of the molecular reagent quality control (QC) function. This includes supervising QC testing of incoming reagents and materials, ensuring compliance with all applicable regulatory requirements (CLIA, CAP, NYS, FDA, ISO, etc.) and managing reagent release processes. The supervisor provides technical guidance, supports process improvement initiatives, and ensures the accuracy, timeliness, and integrity of QC activities supporting molecular testing workflows.

• Supervise daily QC operations for molecular reagents and materials, ensuring all testing is performed according to approved SOPs and regulatory standards.
• Ensure that Quality Control testing of incoming reagents and materials is performed and documented according to applicable procedures.
• Provide technical support and leadership to QC staff performing molecular verification testing, including Next Generation Sequencing (NGS), DNA/RNA extraction and quantification, and other molecular assays.
• Ensure compliance with all applicable laboratory quality and safety regulations (CLIA, CAP, NYS, FDA, ISO).
• Monitor and prioritize workload, ensuring timely testing and release of materials critical to clinical operations.
• Perform or oversee troubleshooting and root cause investigations for QC nonconformances, deviations, and test failures; initiate or contribute to CAPA activities as needed.
• Train and mentor QC personnel, ensuring competency, adherence to SOPs, and ongoing development in molecular QC methods and quality principles.
• Support Change Control implementation and ensuring related documentation (SOPs, forms, QC records) are updated accordingly.
• Maintain equipment and instrument readiness for QC testing, ensuring calibration, preventive maintenance, and documentation are current.
• Review and approve QC records and test data in accordance with Good Documentation Practices (GDP).
• Participate in audits and inspections by providing QC documentation and always ensuring readiness.
• Develop and/or assist with tracking and reporting key performance indicators for reagent QC.
• Identify and implement process improvements to enhance QC efficiency, accuracy, and compliance.
• Promote a culture of quality, safety, and continuous improvement within the Quality Assurance department.
• Perform other duties as assigned.

• Bachelor's degree in a scientific field (Molecular Biology, Biology, Chemistry, Biochemistry, Medical Laboratory Science, or related).
• Minimum 5+ years of experience in a regulated laboratory environment (CLIA, CAP, NYS, FDA, or ISO), including at least 2 years performing or overseeing QC or testing activities.
• Previous experience in supervisory role within a laboratory.
• Demonstrated understanding of molecular laboratory techniques such as NGS, PCR, nucleic acid extraction, quantification, or related assays.
• Strong working knowledge of quality systems, reagent QC processes, and applicable regulatory standards.
• Proficiency in Microsoft Office Suite (Excel, Word, Outlook) and experience with laboratory or quality management systems (LIMS/QMS).

• Master's degree in a scientific discipline.
• ASCP (MB) or ASQ certification.
• Familiarity with GMP/GLP and Good Documentation Practices (GDP).

All job specific, safety, and compliance training are assigned based on the job functions associated with this employee.

This position requires periodic travel and some evenings, weekends and/or holidays.

Individual must successfully complete pre-employment process, which includes criminal background check, drug screening, credit check ( applicable for certain positions) and reference verification. This job description reflects management's assignment of essential functions. Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time.

Caris Life Sciences is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, gender, gender identity, sexual orientation, age, status as a protected veteran, among other things, or status as a qualified individual with disability.

Caris Life Sciences is a leading innovator in molecular science and artificial intelligence focused on fulfilling the promise of precision medicine through quality and innovation. Caris is committed to quality and excellence at our state-of-the- art laboratories. Learn more about our tissue lab and the advanced technologies that are helping improve the lives of cancer patients.