Senior Quality Assurance Specialist/ Quality Assurance Specialist

Tempus AI; Chicago (IL); Presencial; USD 55.000 - 70.000; Jornada completa

Descripción de la vacante

Tempus AI is seeking a meticulous Quality/Documentation Specialist in Chicago to manage Device History Records, SOP updates, and document control workflows within a regulated clinical lab environment. You will ensure compliance with CAP/CLIA/NYS/FDA standards and maintain meticulous quality records.

Ideal candidates have 2–4 years of clerical/documentation experience, are highly organized, and proficient with Microsoft Office and Google Suite.

Formación

• High school diploma required; Bachelors Degree in Science or Engineering preferred.
• 2-4 years of experience with clerical/documentation handling.
• Highly organized and systematic with superb attention to detail.
• Ability to complete repetitive tasks with precision and accuracy.
• Proven ability to learn new skills quickly and adapt to new processes.
• Excellent time management and communication skills.
• Self-driven and thrives in a fast-moving, cross-functional team.
• Ability to create processes/workflows and solve challenges.
• Proficient with Microsoft Office and/or Google Suite.
• Position is onsite; prior CAP/CLIA/NYS/FDA lab exposure desirable.

Responsabilidades

• Compilation and approval of the Device History Record.
• Complete incoming material acceptance activities.
• Update SOPs within the document control system; create/revise SOPs and other quality docs.
• File quality documentation in an organized manner.
• Maintain documentation to satisfy CAP/CLIA/NYS/FDA requirements.
• Provide metrics to identify trends and conduct root cause analysis.
• Report deviations and system deficiencies to management.
• Coordinate Quality tasks with management and testing personnel.
• Pull records/reports during audits.
• Facilitate corrective and preventive actions.
• Track/maintain quality records including batch records and checklists.
• Manage onboarding, offboarding, and transfer duties in electronic QMS.
• Maintain training matrix and document master list.
• Assist in document control workflow as needed.

Conocimientos

Highly organized

Attention to detail

Time management

Communication skills

Self-driven

Cross-functional teamwork

Educación

Bachelor's Degree in Science or Engineering

High school diploma

Herramientas

Microsoft Office

Google Suite

Document control system

Descripción del empleo

Passionate about precision medicine and advancing the healthcare industry? Recent advancements in underlying technology have finally made it possible for AI to impact clinical care in a meaningful way. Tempus' proprietary platform connects an entire ecosystem of real-world evidence to deliver real-time, actionable insights to physicians, providing critical information about the right treatments for the right patients, at the right time.

Responsibilities:

• Compilation and approval of the Device History Record.
• Complete incoming material acceptance activities.
• Read, understand, and update SOPs within the document control system, including creation/revision/review of internal SOPs and other quality documentation.
• File quality documentation in a systematic organized manner.
• Maintain documentation in order to satisfy CLIA/CAP/NYS-DOH/FDA requirements.
• Provide metrics to identify trends and conduct root cause analysis, and develop corrective actions to prevent the recurrence of quality issues.
• Report significant deviations and system deficiencies to management, as appropriate.
• Interact with management and testing personnel to coordinate Quality tasks.
• Pull records and reports as requested during internal and external audits.
• Help facilitate and implement corrective and preventative actions.
• Aid in tracking and maintenance of quality records, including batch records, checklists, competency assessments, quality and equipment binders, and continuing education documentation.
• Complete and maintain onboarding, offboarding, and transfer duties within electronic quality management systems.
• Maintain training matrix and training document master list.
• Assist in document control workflow, as needed.

Qualifications:

• High school diploma required, Bachelors Degree in Science or Engineering preferred.
• 2-4 years of experience with clerical/documentation handling.
• Highly organized and systematic, with superb attention to detail.
• Ability to complete repetitive tasks with a high degree of precision and accuracy.
• Proven ability to learn new skills quickly and adapt to new processes smoothly.
• Excellent time management and communication skills.
• Self-driven and works well in a fast-moving, cross-functional team environment with minimal direction.
• Ability to create processes and workflows, as well as define and create solutions to challenges.
• Intermediate computer skills and software applications, including experience with Microsoft Office tools and/or Google Suite applications.
• This position is onsite.
• Previous experience in a clinical lab regulated by CAP/CLIA/NYS/FDA highly desirable.

CHI: $55,000-$70,000
The expected salary range may vary for other locations. Actual salary may vary based on qualifications and experience. Tempus offers a full range of benefits, which may include incentive compensation, restricted stock units, medical and other benefits depending on the position.

We are an equal opportunity employer. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.