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Sr. Quality Specialist

About us: Lucira Health is a startup striving to transform the way infectious diseases are diagnosed. Lucira Health is the first at-home COVID test authorized by the FDA. Our technology is a single-use, user-friendly COVID test kit that can produce a positive or negative result at home within 30 minutes. This technology bypasses centralized medical lab testing and streamlines patient care. Our current areas of focus include COVID and influenza.

Lucira Health (LHDX) is a disruptive start up democratizing infectious disease testing, putting results in people’s hand in near real time, not hours or days later. The core technology behind our tests have been in development since 2013. The agile nature of our company allows us to quickly adapt and in 2020 we brought the first and only at home molecular COVID-19 test to market. Join us and help change the world of testing.

Position Summary:

The Senior Quality Specialist is responsible for maintaining document control and document archive functions, and for facilitating processes for change control, training systems, and quality metrics reporting.


Core Responsibilities:

  • Maintain a GMP compliant document control function facilitating appropriate processes, procedures, and practices.
  • Work cross-functionally to ensure change orders are executed in a timely manner
  • Maintain and improve processes associated with an electronic document control/training system within Arena
  • Facilitate the process of creating, reviewing, approving and archiving of standard operating procedures (SOPs), Work Instructions, specifications, etc.
  • Ensure current versions of controlled GMP documents are readily available to site personnel.
  • Responsible for Document Control and maintenance of quality records (electronic and hardcopy files) and training records
  • Support computerized system validation (CSV) activities
  • Create and maintain monthly quality metrics reports (change control and training).
  • QA system support during internal and external inspections with document retrieval function, inspection logistics oversight; other functions as required.
  • Support employee onboarding process.
  • Arena PLM/QMS experience preferred Other duties as assigned.

Experience, Requirements and Attributes:

  • 10+ years sales/sales management experience in Medical with B2B experience preferred.
  • Bachelor’s Degree or higher
  • Ability to effectively hire, manage and develop direct reports
  • Well-developed executive communication skills, both written and oral
  • Proactive Leadership style with demonstrated ability to take initiative
  • Strong sense of ownership and accountability
  • Self-starter, able to adapt quickly to change and ambiguous situations.
  • Proven ability to collaborate with internal and external stakeholders to drive results.
  • Proficient computer and data skills- CRM, Excel, PowerPoint and related software.
  • Excellent time management and prioritization skills
  • Able to travel domestically 40%+

Lucira Health is an Equal Opportunity Employer
Individuals seeking employment at Lucira Health are considered without regards to race, color, religion, national origin, age, sex, marital status, ancestry, physical or mental disability, veteran status, gender identity, or sexual orientation.

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