Quality Assurance Associate

Key Responsibilities

• Compilation of the Device History Record.
• Read and understand SOPs within the document control system.
• File quality records in a systematic organized manner.
• Maintain documentation in order to satisfy CLIA/CAP/NYS-DOH/FDA requirements.
• Aid in tracking and maintenance of quality records, including batch records, checklists, and quality and equipment binders.
• Report significant deviations and system deficiencies to management, under guidance and as appropriate.
• Pull records and reports as requested during internal and external audits.
• Help facilitate and implement corrective and preventative actions.
• Other Responsibilities:
• Assist in document control workflow, as needed.
• Manage Supplier Documentation and Compliance, as needed:
• Proactively work with suppliers to ensure documentation on file is up to date
• Send and Review Supplier Questionnaires
• Maintain supplier certificates
• Review and escalate customer and supplier notifications
• Review documents received and escalate any concerns for further review
• Minimum Qualifications/Experience
• High school diploma, Bachelor's Degree in Life Science or Engineering preferred
• 0-2 years of experience in industry or Quality or 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
• Good time management and communication skills
• Self-driven and works well in a fast-moving, cross-functional team environment with minimal direction
• Beginner ability to create processes, as well as suggest solutions to challenges
• Beginner computer skills and software applications, including experience with Microsoft Office tools and/or Google Suite applications
• Preferred Experience
• Previous experience in a clinical lab regulated by CAP/CLIA/NYS/FDA highly desirable
• Chicago/National: $23.00-$26.00/hr
• 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.