JVT Advisors

QA Engineer

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Location: Waltham, Massachusetts 02451
Employment Type: Contract

Job Description

Contract Length: 10 months with possible extension; 100% remote with some travel

Job Summary: The Quality Assurance Lead will be responsible for providing guidance and direction on quality requirements, agreements and activities conducted by the company’s employees and contracted laboratories. They will provide day-to-day support in CLIA and laboratory requirements as well as develop and maintain quality procedures and activities required to uphold effective operations.

Responsibilities:

  • Develop Quality Agreements between PerkinElmer and contracted laboratories
  • Revise the HUB Quality Management Plan (QMP0 as required per contractual agreement
  • Provide Quality support during inspection of PerkinElmer Hub or contracted partners
  • Manage the contracted laboratory audit schedule and process; maintain all records of qualification and for cause audits
  • Conduct remote or in person audits of laboratories

Requirements:

  • Bachelor's Degree in Health Sciences or relevant field; or equivalent work experience.
  • Combined 10+ years of experience in Quality Assurance and Clinical Laboratory Management with a minimum of 5 years in Quality Assurance.
  • Certified Lead Auditor, CLIA
  • Education:
    • BS, MS, or PhD with a degree in chemical, physical or biological science or medical laboratory technology. OR o Associate Degree in laboratory science, or medical laboratory technology prior to April 25, 1995 OR
    • High School diploma prior to April 25, 1995 AND either:
    • Graduate of MLT or CLT program or
    • Hold a US military Medical Lab Specialist Certification
    • Copy of the diploma, that states the type of chemical, physical, biological, or clinical laboratory/medical technology science degree and the major discipline MUST BE PROVIDED

Trevor Hoffman

Technical Recruiter

Trevor recruits for JVT's Life Sciences and Technology Practices where he specializes in finding, screening, and placing top-tier industry innovators at companies across multiple markets and verticals.

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