QA Specialist

Phoenix, Arizona, United States

You are a highly skilled quality professional with experience working in a clinical laboratory. You have developed a QMS structure encompassing all the Quality Elements required to meet CLIA and CAP regulations in a startup environment. You are meticulous at building and maintaining quality systems. You are highly motivated to ensure documentation reflects the regulations and that staff are trained to utilize the QMS effectively and efficiently.

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

  • Build, with laboratory management and testing personnel, the Quality Management System (QMS) for a CLIA and CAP laboratory. NYS DOH & CA regulated laboratory a plus.
  • Craft, own and update SOPs, forms, guides and records for use in the laboratory to ensure CLIA certification and regulatory compliance.
  • Create and assist laboratory management in training programs and documentation for laboratory processes.
  • Lead occurrence management process including CAPAs for the CLIA laboratory.
  • Assemble feedback on documentation for continuous improvement.
  • Handle documentation for supplier evaluations, equipment, and other laboratory support tasks.
  • Manage all quality personnel files for CLIA laboratory and ensures compliance.
  • Assign training to personnel and appropriate follow-up to maintain compliance as required.
  • Manage records of external regulations, standards and other guidance.
  • Assist with creating regulatory compliant training and competencies.
  • Schedule and perform assessments and audits with Laboratory Management to ensure regulatory compliance.
  • Ensure documentation of evidence of compliance, corrective actions, and other appropriate actions in the QMS.
  • Participate in the change management process to ensure all changes are reflected in appropriate documentation.
  • Engage with personnel submitting laboratory documents or approving laboratory documents.
  • Check documents submitted to document control for compliance with Quality Management System templates and good documentation practices. ISO 13485 knowledge a plus.

What you'll bring

  • 3+ years of laboratory experience, clinical experience a plus.
  • Broad knowledge and experience in: Document control, Laboratory Processes, LIMS, CLIA and CAP. NYS DOH and CA knowledge and experience.
  • Above average skills in the use of MS Office (or equivalent), communications and tenacious attention to detail.
  • General knowledge of: Document control process and regulatory compliance.
  • Tenacious attention to detail and consistency, especially with respect to grammar, usage, spelling, punctuation and style
  • Ability to prioritize and multitask while maintaining a positive and collaborative attitude.
  • Excellent collaborative skills and the ability to interface effectively with a wide range of stakeholders.
  • Flexibility to support changing assignments and priorities in an independent and reliable manner.

About Us

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 over 5 million 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 workforce 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.  If you are unable to submit your application because of incompatible assistive technology or a disability, please contact us at accommodations-ext@23andme.com. 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.