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.
We are looking for a Quality Assurance Associate who will be responsible for documenting and tracking compliance for an IVD medical device manufacturer and clinical molecular laboratory. This individual will play an integral role in supporting quality assurance activities in accordance with FDA QSR (Quality System Regulation), ISO 13485, and other applicable global regulations, including but not limited to records management, acceptance activities, production and process control. This individual also supports the QMS activities that comply with CAP/CLIA requirements for the clinical laboratories.
Key Quality Assurance AssociateResponsibilities:
- 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.
Other Quality Assurance Associate Responsibilities:
- 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.
Qualifications
- 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
Preferred Experience
- Previous experience in a clinical lab regulated by CAP/CLIA/NYS/FDA highly desirable
#LI-SH1
#LI-Hybrid
