Azenta Life Sciences · 2 days ago

Senior Quality Associate

Billerica, MA

Full-time

Onsite

Senior Level

4+ years exp

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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 system 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®.

Qualification

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Quality AssuranceInternal AuditsISO 9001Microsoft OfficeGxP FacilityProblem-SolvingCreativityLeadershipCommunicationInterpersonal SkillsCollaborationInitiativeIndependenceContinuous improvementProject managementSix sigma