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.
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:
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Associate's Degree / certificate, B.A., B.S., or equivalent. Work experience may be considered in lieu of education
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2+ year of work experience in Clinical Laboratory or Biotech industry preferred or a relevant combination of skills, education, and experience
OUR OPPORTUNITY
Natera™ is a global leader in cell-free DNA (cfDNA) testing, dedicated to oncology, women’s health, and organ health. 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.
The Natera team consists of highly dedicated statisticians, geneticists, doctors, laboratory scientists, business professionals, software engineers and many other professionals from world-class institutions, who care deeply for our work and each other. When you join Natera, you’ll work hard and grow quickly. Working alongside the elite of the industry, you’ll be stretched and challenged, and take pride in being part of a company that is changing the landscape of genetic disease management.
WHAT WE OFFER
Competitive Benefits - Employee 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 benefits and much more. We also offer a generous employee referral program!
For more information, visit www.natera.com.
Natera is proud to be an Equal Opportunity Employer. We are committed to ensuring a diverse and inclusive workplace environment, and welcome people of different backgrounds, experiences, abilities and perspectives. Inclusive collaboration benefits our employees, our community and our patients, and is critical to our mission of changing the management of disease worldwide.
All qualified applicants are encouraged to apply, and will be considered without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, age, veteran status, disability or any other legally protected status. We also consider qualified applicants regardless of criminal histories, consistent with applicable laws.
If you are based in California, we encourage you to read this important information for California residents.
Link: https://www.natera.com/notice-of-data-collection-california-residents/
Please be advised that Natera will reach out to candidates with a @natera.com email domain ONLY. Email communications from all other domain names are not from Natera or its employees and are fraudulent. Natera does not request interviews via text messages and does not ask for personal information until a candidate has engaged with the company and has spoken to a recruiter and the hiring team. Natera takes cyber crimes seriously, and will collaborate with law enforcement authorities to prosecute any related cyber crimes.
For more information:
- BBB announcement on job scams
- FBI Cyber Crime resource page