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Quality Assurance Specialist

Company: Natera Inc
Location: San Carlos
Posted on: November 22, 2021

Job Description:

POSITION SUMMARY: The Quality Assurance Specialist works with the Quality Department in continuous compliance and improvement. PRIMARY RESPONSIBILITIES: * Collecting and trending quality metrics * Work to assign IDs for CAPAs, Deviations, SCAR, Complaints, and NCRs and filing completed records. * Partner to provide review and approval of qualification records * Participate in Quality System related meetings (as needed) * Assist with obtaining documentation and supporting the team during audits * Work to help schedule Internal Audits * Stays current on applicable regulation and guidance from FDA, ISO13485, CLIA, CAP, etc * 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 offer criminal background check. * Performs other duties as assigned QUALIFICATIONS: * Bachelor's Degree in Life Sciences, Engineering, Software or equivalent * 1+ year of working experience in Biotech industry preferred Or a relevant combination of skills, education, and experience KNOWLEDGE, SKILLS, AND ABILITIES: * Independent and self-starter with organizational and planning skills * Excellent written and verbal communication * Interpersonal skills are desired with the ability to be flexible and collaborate with others * Ability to use Microsoft Word, PowerPoint, Excel, Google Documents * Ability to prioritize and multi-task in a fast-paced environment PHYSICAL DEMANDS & WORK ENVIRONMENT: * Ability to be flexible with working hours (as needed). * Ability to work and thrive in a fast-paced environment. Travel required for this position: No or Yes : If yes state anticipated percent for travel: N/A UR OPPORTUNITY Driven by the passion for elevating the science and utility of genetic testing, Natera is committed to helping families identify and manage genetic diseases. Natera is a rapidly-growing diagnostics company with proprietary bioinformatics and molecular technology for analyzing DNA. Our complex technology has been proven clinically and commercially in the prenatal testing space and we are actively researching its applications in the liquid biopsy space for developing products with oncology applications. 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! 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. For more information, visit www.natera.com.

Keywords: Natera Inc, San Francisco , Quality Assurance Specialist, Other , San Carlos, California

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