Position Summary
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. Represents the document, records, and provides general support for internal and external audits. Support the maintenance of the employee roster for laboratory personnel and monitor for maintenance of appropriate credentials.
Represents the training processes for internal and external audits
PRIMARY RESPONSIBILITIES:
- Under direct supervision, stays current on applicable regulation and guidance from FDA, ISO13485, CLIA, CAP, etc. Coordinate with IT for maintenance of the eQMS and systems containing training, credentials, and delegation content. Provide training and access oversight for the quality system processes within the eQMS; maintain document collections in the EDMS; manage periodic review and archival activities for controlled documents and records to meet requirements of QSR 820, ISO 13485, CLIA, CAP and state standards; provide administrative oversight of quality system processes, collects and provide reports of quality metrics to monitor the effectiveness of the quality management system, retrieves quality documents and records; supports internal/external audits; maintain company training presentations and records; collect and trend quality metrics. Expands skills as QA professional through execution of duties, independent learning, training courses, and receiving mentoring. Performs other duties as assigned.
QUALIFICATIONS:
- Associate’s degree / certificate, B.A., B.S., or equivalent. Work experience may be considered in lieu of education
- 0-2 year of work experience in Biotech industry preferred or a relevant combination of skills, education, and experience
KNOWLEDGE, SKILLS, AND ABILITIES:
- Computer skills (MS Word, Excel, PowerPoint, etc.)
- Good technical writing and communication skills, independent worker, a self-starter with strong organizational and planning skills
- Has an ability to be productive and successful in an intense work environment Preferred skills:
- Demonstrates good judgment, excellent attention to detail, excellent written, verbal communication and interpersonal skills are desired with the ability to be flexible and collaborate on multiple projects
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. This may differ in other locations due to cost of labor considerations.San Carlos, CA $27—$35 USD
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
