Natera
QASpecialist
Neural analysis suggests this role is
optimal for Mid+ candidates.
“QA Specialist at Natera. Skills: quality assurance, process management, documentation control, vendor/stakeholder management. day to day management and operations of the facility, products and vendors. ensures safety, quality and compliance with all relevant procedures, state and federal regulations and customer expectations”
What You'll Achieve.
ensures safety, quality and compliance with all relevant procedures, state and federal regulations and customer expectations
Industry & Context.
effective problem solving; active management of ambiguous situations
Work with PHI on a regular basis both in paper and electronic form, access to various technologies to access PHI (paper and electronic), complete training relating to HIPAA/PHI privacy, General Policies and Procedure Compliance training and security training within the first 30 days of hire, maintain a current status on Natera training requirements, pass post post-offer criminal background check
What They're Looking For.
Must Have
Associate's Degree / certificate, B. A. , B. S. , or equivalent, Work experience may be considered in lieu of education, Employee must complete training relating to HIPAA/PHI privacy, General Policies and Procedure Compliance training and security training as soon as possible but not later than the first 30 days of hire., Must maintain a current status on Natera training requirements., Employee must pass post post-offer criminal background check.
Nice to Have
2+ year of work experience in Clinical Laboratory or Biotech industry preferred or a relevant combination of skills, education, and experience
What You'll Do.
day to day management and operations of the facility
quality and compliance with all relevant procedures
state and federal regulations and customer expectations
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
participate in Quality System related meetings (as needed).
collect and trend quality
provide administrative oversight of QMS processes (e. g. Document Control
Stays current on applicable regulation and guidance from FDA
May serve as scribe or provide other support for internal/external audits
including serving as an internal auditor.
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.
Performs other duties as assigned.
Expands skills as QA professional through execution of duties
and receiving mentoring.
How You'll Work.
Team & Collaboration
cross-functional coordination; participate in Quality System related meetings (as needed); May serve as scribe or provide other support for internal/external audits
Communication Scope
outstanding communication
Full Job Description
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 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. Employee must complete training relating to HIPAA/PHI privacy, General Policies and Procedure Compliance training and security training as soon as possible but not later than the first 30 days of hire. Must maintain a current status on Natera training requirements. Employee must pass post post-offer criminal background check. Performs other duties as assigned. Expands skills as QA professional through execution of duties, independent learning, training courses, and receiving mentoring. QUALIFICATIONS: Associate's Degree / certificate, B.A., B.S., or equivalent. Work experience may be consi
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