Job Description

Description

The Quality Assurance (QA) Specialist II is responsible for supporting and executing core quality system processes within a cGMP-regulated manufacturing environment. This role focuses heavily on supplier quality management, audit execution, CAPA coordination, and quality systems oversight.

Key Responsibilities Include:

  • Managing supplier relationships and ensuring compliance with quality requirements
  • Conducting supplier audits (on-site and remote)
  • Supporting CAPA, change control, and nonconformance processes
  • Leading supplier qualification and maintaining approved supplier lists
  • Investigating product complaints and coordinating corrective actions
  • Supporting regulatory inspections and internal audits
  • Reviewing SOPs and maintaining compliance with cGMP standards
  • Driving process improvements and quality initiatives across teams

    • This individual will collaborate with cross-functional...

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