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QA / RA Manager

QA / RA Manager

Pillar BiosciencesNatick, MA, US
30+ days ago
Job type
  • Full-time
Job description

Qa / Ra Manager

Pillar Biosciences is looking to disrupt the next-generation sequencing diagnostic space with our fabulous product and our ability to offer de-centralized testing vs sending samples to external labs. We can get results in 1 day and get patients on the precise medicine they need.

The QA / RA Manager leads planning, development and improvement of Pillar's Quality Management System to support product, compliance and commercialization goals. In this role, you will :

  • Serve as the QA / RA Lead in cross-functional development projects
  • Develop, manage and maintain the documentation systems
  • Develop quality system procedures, instructions and forms throughout process
  • Own the core quality system processes
  • Oversee training, develop, and deliver training for Quality Management System processes
  • Generate metrics for critical-to-quality process
  • Participate and drive quality process improvement initiatives and project teams
  • Assist in establishing processes and procedures to enable international entry
  • Review and approve internal CAPAs, Change Controls, Deviations and other quality processes

Requirements :

  • Masters Degree in Bioengineering, Industrial Engineering or a closely-related field
  • Three (3) years of quality assurance experience
  • Minimum one (1) year working in ISO 13485 certified or FDA regulated environment
  • Must be ISO 13485 certified in minimum of two management systems competencies
  • This is an on-site role, Monday - Friday from 8 : 30am - 5 : 00pm in Natick MA. Relocation support is not available for this role.

    $150,322 - $150,323 a year

    Pillar Biosciences aims to "Make precision medicine the first option for every patient" by developing and manufacturing targeted next-generation sequencing (NGS)-based assays and software for today's high-throughput specialty NGS laboratories. We are seeking collaborative and independent problem solvers to support our mission.

    Pillar Biosciences is an Equal Opportunity and Affirmative Action employer committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; religion; age; nationality; marital status; sexual orientation; disability or any other characteristic protected by law.

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    Manager • Natick, MA, US