QA Specialist

Natera • US Remote, CA

1d • $79,700 - $99,600 • Remote

About The Position

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. 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.

Requirements

• Associate's Degree / certificate, B.A., B.S., or equivalent. Work experience may be considered in lieu of education
• 2+ year of work experience in Clinical Laboratory or Biotech industry preferred or a relevant combination of skills, education, and experience

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 documentation.
• 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.

Benefits

• comprehensive medical, dental, vision, life and disability plans for eligible employees and their dependents
• free testing
• fertility care benefits
• pregnancy and baby bonding leave
• 401k benefits
• commuter benefits
• generous employee referral program

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Associate degree