Must maintain a current status on Natera training requirements.
Employee must pass post post-offer criminal background check.
Associate's Degree / certificate, B.A., B.S., or equivalent. Work
experience in Clinical Laboratory or Biotech industry preferred or a relevant combination of skills, education, and experience
Natera™ is a global leader in cell-free DNA (cfDNA) testing, dedicated to oncology, women’s health, and organ health.
Experience
experience may be considered in lieu of education • 2+ year of work
Benefits
The pay range is listed and actual compensation packages are based on a wide array of factors unique to each candidate, including but not limited to skill set, years & depth of experience, certifications and specific office location.
Remote USA $79,700 — $99,600 USD OUR OPPORTUNITY
Our aim is to make personalized genetic testing and diagnostics part of the standard of care to protect health and enable earlier and more targeted interventions that lead to longer, healthier lives.
benefits include comprehensive medical, dental, vision, life and disability plans for eligible employees and their dependents.
Additionally, Natera employees and their immediate families receive free testing in addition to fertility care benefits. Other
benefits include pregnancy and baby bonding leave, 401k benefits, commuter
The Quality Assurance Specialist participates in the day to day management and operations of the facility, products and vendors.
Through outstanding communication, effective problem solving, and active management of ambiguous situations, the Quality Assurance Specialist ensures safety, quality and compliance with all relevant procedures, state and federal regulations and customer expectations. PRIMARY RESPONSIBILITIES:
Assist Natera employees with recommendations regarding the release, structure and change of all controlled documentation, training plan establishment and maintenance.
Assist in the creation of new and/or revision of existing documents and training plans for multiple functional teams. Manages release and control of updates to Quality System & Product supporting documentation and assures data security.
Manages the operation of the EDMS to ensure that all users have the latest revision of appropriate
Partner with users to provide review and approval of documents and records; participate in Quality System related meetings (as needed).
Under direct supervision, collect and trend quality metrics; provide administrative oversight of QMS processes (e.g. Document Control, Trainig CAPAs, deviations, SCARs, complaints, and NCRs)
Stays current on applicable regulation and guidance from FDA, ISO13485, CLIA, CAP, etc
May serve as scribe or provide other support for internal/external audits, including serving as an internal auditor.
This role works with PHI on a regular basis both in paper and electronic form and has access to various technologies to access PHI (paper and electronic) in order to perform the job.