Quality Assurance Specialist

This position is onsite in Chicago and requires you to work Tuesday–Saturday or Sunday–Thursday.

Responsibilities

• Compile and approve the Device History Record.
• Complete incoming material acceptance activities.
• Read, understand, and update SOPs within the document control system, including creation, revision, and review of internal SOPs and other quality documentation.
• File quality documentation in a systematic, organized manner.
• Maintain documentation to satisfy CLIA, CAP, NYS-DOH, and FDA requirements.
• Provide metrics to identify trends, conduct root cause analysis, and develop corrective actions to prevent 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; Bachelor’s Degree in Science or Engineering preferred.
• 2–4+ years of experience with clerical/documentation handling.
• Previous experience in a clinical lab regulated by CAP, CLIA, NYS, or FDA highly desirable.
• 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.

Pay

Illinois Pay Range: $55,000–$70,000. The expected salary range may vary for other locations. Actual salary may vary based on qualifications and experience.

Benefits

Tempus offers a full range of benefits, which may include incentive compensation, restricted stock units, medical and other benefits depending on the position.