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Lab Operations Quality Specialist
Mountain View, CA, United States
23andMe is seeking a talented Lab Operations Quality Specialist who will be responsible for maintaining quality assurance standards that adhere to quality system requirements (21 CFR 820), ISO regulations (ISO 13485), CLIA and CAP.
Who we are
Since 2006, 23andMe’s mission has been to help people access, understand, and benefit from the human genome. We are a group of passionate individuals pushing the boundaries of what’s possible to help turn genetic insight into better health and personal understanding.
What you'll do
- Act as the specialist for document control and metrics for the Lab Operations team
- Create, revise and maintain standard operating procedures and work instructions
- Create and maintain documentation for quality activities
- Interact with RA/QA to ensure all laboratories performances meet regulatory requirements
- Execute projects as directed by Lab Ops management
- Minimal travel (~ 10%) to visit contracted laboratories and attend conferences
What you'll bring
- Minimum of two years' quality assurance or related experience at a medical device company and/or CLIA laboratory
- Bachelor’s degree or equivalent experience
- Experience in or significant exposure to Validation and/or QA/QC in a regulated scientific industry (e.g., in vitro diagnostics or medical testing, CLIA or GLP laboratory, GMP manufacturing) and experienced with key concepts of operating under a Quality System (21 CFR 820, ISO13485, ISO14971)
- Excellent communication and interpersonal skills, with demonstrated ability to explain technical concepts and details to diverse audiences (e.g., technical staff, business management, research colleagues, product & engineering colleagues, vendors, and customers)
- Ability to prioritize, multitask, and maintain a positive attitude in dealing with internal and external partners
- Strong work ethic and desire to deliver work of the highest quality
- Ability to work independently with minimum supervision and with a high degree of autonomy and accountability
23andMe, Inc. is the leading consumer genetics and research company. Our mission is to help people access, understand and benefit from the human genome. The company was named by MIT Technology Review to its “50 Smartest Companies, 2017” list, and named one of Fast Company’s “25 Brands That Matter Now, 2017”. 23andMe has millions of customers worldwide, with ~85 percent of customers consented to participate in research. 23andMe is located in Mountain View, CA. More information is available at www.23andMe.com.
At 23andMe we value a diverse, inclusive work force and we provide equal employment opportunity for all applicants and employees. All qualified applicants for employment will be considered without regard to an individual’s race, color, sex, gender identity, gender expression, religion, age, national origin or ancestry, citizenship, physical or mental disability, medical condition, family care status, marital status, domestic partner status, sexual orientation, genetic information, military or veteran status, or any other basis protected by federal, state or local laws. 23andMe will reasonably accommodate qualified individuals with disabilities to the extent required by applicable law.
Please note: 23andMe does not accept agency resumes and we are not responsible for any fees related to unsolicited resumes. Thank you.