Tempus Labs, Inc. is hiring a
Quality Assurance Associate
Tempus Labs, Inc.
π΅ ~$95k-$120k
πUnited States
Please let Tempus Labs, Inc. know you found this job on JobsCollider. Thanks! π
Summary
Join our team as a Quality Assurance Associate and contribute to advancing precision medicine and healthcare industry. As a key member of our quality assurance activities, you will document and track compliance for an IVD medical device manufacturer and clinical molecular laboratory, ensuring adherence to FDA QSR, ISO 13485, and other applicable regulations.
Requirements
- High school diploma
- 0-2 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
- 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
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, competency assessments, quality and equipment binders, and continuing education documentation
- 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
- Complete and maintain onboarding, offboarding, and transfer duties within electronic quality management systems
- Maintain training matrix and training document master list, with guidance
- Assist in document control workflow, as needed
Preferred Qualifications
Previous experience in a clinical lab regulated by CAP/CLIA/NYS/FDA highly desirable
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