Quality Specialist

    • Irvine, CA

SCHEDULE:  Mon - Fri, traditional PST hours

Invitae is dedicated to bringing comprehensive genetic information into mainstream medicine to improve healthcare for billions of people. Our team is driven to make a difference for the patients we serve. We are leading the transformation of the genetics industry, by making clinical-grade genetic information affordable and accessible to guide health decisions across all stages of life. 

Our team is expanding rapidly and we’re looking for people who are passionate about helping improve healthcare to join us. 

What you’ll do:

  • Support Corrective and Preventive Action Program
  • Provide CAPA reports for completion as necessary, update tracking log and report monthly metrics
  • Support Change Control Program, provide Change Control Reports for completion as necessary, update tracking log and report monthly metrics
  • Support external and internal proficiency testing schedules
  • Coordinate sample selection, accessioning and result review
  • Provide support and coverage of Document Control System
  • Manage the preparation for and participate in on-site and external inspections by regulatory agencies including but not limited to CAP, CLIA, and NYS

  • Respond to recommended corrective action through process revision and preparation of reports.

  • Support regulatory submission process
  • Create new employee training files, periodically audit, maintain accurate and complete records

  • Support Continuing Education Program to ensure all technical staff complete the required CEUs annually to meet regulatory requirements.

  • Track and provide periodic reports on training and competency of technical and clinical staff

  • Prepare and update Quality metrics reports as necessary to enhance and effectively communicate department performance

  • Support quality improvement initiatives and other PQM programs including but not limited to equipment, safety and supply management

  • Collaborate with and support Irvine Lab Operations and the Laboratory Director
  • Plan, prepare, and host site quality meetings

What you bring:

  • Minimum of 3+ years Quality experience in a laboratory environment
  • Possess a Bachelor’s degree

By joining Invitae, you’ll work alongside some of the world’s experts in genetics and healthcare at the forefront of genetic medicine. We’ve created a culture that empowers our teams and our teammates to have the biggest impact and to explore their interests and capabilities. We prize freedom with accountability and offer significant flexibility, along with excellent benefits and competitive compensation in a fast-growing organization. 

Join us.

At Invitae, we value diversity and provide equal employment opportunities (EEO) to all employees and applicants without regard to race, color, religion, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status. We will consider for employment qualified applicants with criminal histories in a manner consistent with the requirements of the San Francisco Fair Chance Ordinance.

Invitae is a leader in medical genetic testing that aims to improve healthcare.

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