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Quality and Compliance Manager, Laboratory Operations

Passionate about making a difference in the world of cancer genomics?

With the advent of genomic sequencing, we can finally decode and process our genetic makeup. We now have more data than ever before but providers don't have the infrastructure or expertise to make sense of this data. We're on a mission to connect an entire ecosystem to redefine how genomic data is used in clinical settings. We are looking for a Quality and Compliance Manager who will be responsible for regulatory compliance for a clinical sequencing lab.

  • Oversee quality assurance, quality control activities and quality management system related to laboratory operations
  • Create, implement and maintain key quality systems, including quality protocol investigation reports (CAPA, etc.), audit reports, protocols, regulatory submissions
  • Report significant investigation/deviation issues and system deficiencies to senior management, as appropriate
  • Manage internal document control system, including creation/ revision/ review of internal SOPs and other quality documentation
  • Perform internal quality audits and facilitate preventative and corrective actions
  • Manage internal training program and personnel documentation
  • Review and approve protocols and validation summaries
  • Ensure proper maintenance of lab equipment
  • As necessary, supervise and/or provide QA/QC and regulatory guidance to clinical, laboratory, development and/or scientific staff

Required Knowledge and Skills

  • Highly organized and systematic, superb attention to detail and ability to complete tasks with a high degree of accuracy
  • Previous quality control experience in a clinical lab regulated by CAP/ CLIA/ NYS highly desirable
  • Bachelor’s degree required

 

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