Quality Systems Specialist at Tempus
Are you passionate about using technology to improve the lives of patients?
Are you passionate about building a laboratory that changes the way infectious diseases are detected and treated over the coming decade?
With the advent of molecular testing, we can finally decode and process our genetic makeup. We now have more data than ever before but providers don't have the infrastructure or expertise to make sense of this data. We're on a mission to connect an entire ecosystem to redefine how molecular data is used in clinical settings.
Moreover, we are leveraging technology and data to fight against COVID-19 and to build a system to ensure that future pandemics can be detected and treated faster, more effectively and with better use of data. We are looking for the best and brightest to help us build this new paradigm in infectious disease treatment.
What You’ll Do:
- Collaborate cross-functionally to support the maintenance and improvement of Tempus’ Quality Management System (QMS).
- Lead, coordinate and support various QMS activities such as:
- Maintenance of training plans and training records, including job descriptions and CVs
- Corrective and preventive actions (CAPAs)
- Non-conformances and deviations
- Batch-records/DHRs (Device History Records)
- Record and Change controls
- Supplier Corrective Action Requests (SCARs)
- Maintenance of quality metrics across all QMS functional areas and perform data analysis to identify opportunities for quality improvement
- Customer complaints and issue management
- Internal and external quality audit readiness, and support
- Support laboratory quality operations such as monitoring and tracking pre-analytical, analytical, and post analytical performance, and advising the QA Manager when performance standards are not met.
- Support the lab quality team in maintaining Tempus’ state and federal licensure, and CAP/CLIA/NYS/FDA regulatory compliance.
- Writing and reviewing QMS procedures, verification/validation protocols and reports as required.
- May be required to assist the QA Engineering group with activities associated with equipment, instrument, utilities, and/or facility qualification activities including change control, and support of site programs.
- Other duties as assigned.
- Bachelor’s degree required preferably in a life science discipline.
- Minimum of 4 years of QMSexperience in the FDA regulated industry - medical devices or IVDs.
- Experience with FDA QSR and ISO 13485 quality system requirements
- Some QA experience in a molecular testing laboratory (LDTs) is a plus.
- Strong interpersonal skills in the areas of written and verbal communication.
- Must be creative, flexible, and able to prioritize and handle multiple projects concurrently.
- Must be self-motivated and have the ability to work with minimal supervision.