Job Description

Job Title: Quality Assurance Engineer – External

Job Description

The Quality Assurance Engineer – External plays a key role in overseeing external quality operations, with a focus on Contract Manufacturing Organizations (CMOs), material suppliers, service providers, and contract laboratories. You will assess compliance with current Good Manufacturing Practices (cGMPs), review batch records and change controls, and ensure adherence to applicable regulations and internal policies. This role combines supplier auditing, quality oversight, and performance monitoring, and requires periodic travel.

Responsibilities

  • Conduct external quality assurance activities for CMOs, material suppliers, service providers, and contract laboratories to ensure compliance with cGMPs, applicable regulations, and internal company policies.
  • Ensure suppliers meet industry and company standards as defined by regulatory agencies and internal standard operating...

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