Senior Quality Assurance & Documentation Specialist

Tempus AI; Chicago (IL); Sur place; USD 55 000 - 70 000; Plein temps

Résumé du poste

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.

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 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.

Responsabilités

• 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.

Connaissances

Highly organized

Attention to detail

Time management

Communication skills

Self-driven

Cross-functional teamwork

Formation

Bachelor's Degree in Science or Engineering

High school diploma

Outils

Microsoft Office

Google Suite

Document control system

Description du poste

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.