Caris Life Sciences
Quality Assurance Analyst - Equipment
Caris Life Sciences, Phoenix, Arizona, United States, 85003
Join Us In Our Mission To Improve The Human Condition
At Caris, we understand that cancer is an ugly worda word no one wants to hear, but one that connects us all. That's why we're not just transforming cancer carewe'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 healthcaredriven 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. Position Summary
The Quality Assurance Analyst-Equipment position is responsible for assisting in company-wide compliance to all applicable regulatory requirements and assisting with the day-to-day operations of the laboratory's equipment calibration and maintenance program. Job Responsibilities
Maintain compliance to all applicable regulatory requirements (CLIA, NYS, CAP, ISO, FDA, IVDD, etc.) with regards to laboratory instrumentation calibration and maintenance. Collaborate with cross-functional teams to achieve defined business objectives. Manage company records in accordance with regulatory requirements and company policies. Coordinate with approved vendors and laboratory staff to coordinate equipment calibrations, preventative maintenance, and repairs. Perform equipment repairs, calibrations, and preventative maintenance, as required. Use problem solving skills to identify, solve problems, or improve processes. Author, review, revise, and implement standard operating procedures (SOPs) for the QMS. Participate in internal and external audits with tasks such as audit preparation, answering questions, and providing documentation to auditors. Train new hires/other team members on analyst job functions. Manage equipment projects such as SOP revisions, implementation of new processes, and management of the pipette program. Required Qualifications
Three years of experience working in a regulated environment (CAP, CLIA, NYS, FDA, ISO, etc.) or Bachelor's degree in a scientific field. Preferred Qualifications
Bachelor's degree and three years of experience working in a quality role within regulated laboratory environment. A certification by the American Society for Quality (ASQ) or equivalent. Physical Demands
Employee may be required to lift or reposition laboratory equipment and accessories. Employee must be able to use standard office equipment. Employee must have ability to sit and stand for extended periods of time. Work is split between a desk/cubicle environment and a laboratory environment. Employee may have exposure to high noise levels, fumes, and biohazardous materials in the laboratory environment. Training
All job specific, safety, and compliance training are assigned based on the job functions associated with this employee. Other
This position requires periodic travel and some evenings, weekends, and/or holidays. Conditions of Employment: Individual must successfully complete pre-employment process, which includes criminal background check, drug screening, credit check (applicable for certain positions) and reference verification. 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.
At Caris, we understand that cancer is an ugly worda word no one wants to hear, but one that connects us all. That's why we're not just transforming cancer carewe'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 healthcaredriven 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. Position Summary
The Quality Assurance Analyst-Equipment position is responsible for assisting in company-wide compliance to all applicable regulatory requirements and assisting with the day-to-day operations of the laboratory's equipment calibration and maintenance program. Job Responsibilities
Maintain compliance to all applicable regulatory requirements (CLIA, NYS, CAP, ISO, FDA, IVDD, etc.) with regards to laboratory instrumentation calibration and maintenance. Collaborate with cross-functional teams to achieve defined business objectives. Manage company records in accordance with regulatory requirements and company policies. Coordinate with approved vendors and laboratory staff to coordinate equipment calibrations, preventative maintenance, and repairs. Perform equipment repairs, calibrations, and preventative maintenance, as required. Use problem solving skills to identify, solve problems, or improve processes. Author, review, revise, and implement standard operating procedures (SOPs) for the QMS. Participate in internal and external audits with tasks such as audit preparation, answering questions, and providing documentation to auditors. Train new hires/other team members on analyst job functions. Manage equipment projects such as SOP revisions, implementation of new processes, and management of the pipette program. Required Qualifications
Three years of experience working in a regulated environment (CAP, CLIA, NYS, FDA, ISO, etc.) or Bachelor's degree in a scientific field. Preferred Qualifications
Bachelor's degree and three years of experience working in a quality role within regulated laboratory environment. A certification by the American Society for Quality (ASQ) or equivalent. Physical Demands
Employee may be required to lift or reposition laboratory equipment and accessories. Employee must be able to use standard office equipment. Employee must have ability to sit and stand for extended periods of time. Work is split between a desk/cubicle environment and a laboratory environment. Employee may have exposure to high noise levels, fumes, and biohazardous materials in the laboratory environment. Training
All job specific, safety, and compliance training are assigned based on the job functions associated with this employee. Other
This position requires periodic travel and some evenings, weekends, and/or holidays. Conditions of Employment: Individual must successfully complete pre-employment process, which includes criminal background check, drug screening, credit check (applicable for certain positions) and reference verification. 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.