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Senior Quality Associate

2 months ago

Billerica, Massachusetts, United States GENEWIZ Full time

About the Role

We are seeking a highly skilled Senior Quality Associate to join our team at Azenta Life Sciences. As a key member of our quality assurance team, you will be responsible for providing quality assurance support for our customer and regional sites.

Key Responsibilities

  • Independently schedule and host client audits and respond to audit findings in a timely manner.
  • Conduct internal audits for all North American Azenta Life Sciences facilities, including regional and client sites.
  • Assist with implementation and improvement of quality systems globally within Azenta Life Sciences through gap analysis and remediation – as needed.
  • Routinely review and approve equipment validation documents – such as temperature mapping, calibration, alarm validations, etc.
  • Compile the Management Review Meeting Presentation, including interpretation of data, charts, etc.
  • Review Change Request for Global Operations
  • Provide direction and leadership to ensure compliance with GxPs, ISO 9001, federal and local guidelines and regulations at Customer and Regional Sites.
  • Provide regional QA support, as needed
  • Act as system administrator in Qualtrax.

Requirements

  • Four-year degree, preferred Life Sciences/ Engineering
  • 4 years' experience in Quality Assurance
  • Experience performing internal audits
  • Experience with ISO 9001
  • Strong analytical skills and the ability to think creatively
  • Excellent leadership skills and the ability to work across the organization
  • Strong communication, interpersonal, and collaborative skills
  • Demonstrated high level of initiative and the ability to work independently
  • Proficiency in Microsoft Office Products
  • Experience in GxP facility preferred
  • Experience with Continuous Improvement initiatives preferred
  • Experience with project management preferred
  • Six Sigma certification preferred

Working Conditions

  • May work with potentially infectious materials.
  • Responsible for maintaining a clean work environment and enforcing and following Universal Precautions for bloodborne pathogens when working in areas considered to be potentially contaminated

Equal Employment Opportunity

Azenta Life Sciences is an equal employment opportunity employer and welcomes applications from diverse candidates.