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Quality Assurance Auditor - Manufacturing

Catalent

Quality Assurance Auditor role at a pharmaceutical oral solid dose manufacturing facility in Greenville, North Carolina. Responsible for ensuring cGMP compliance, data integrity, batch record review, and real-time quality support across manufacturing and packaging operations.

Responsibilities

  • Ensure data integrity and accurate documentation of all cGMP activities and transactions
  • Perform in-process quality checks and assure material release prior to manufacturing operations
  • Review batch records and provide real-time support to manufacturing and packaging teams
  • Monitor compliance with internal, client-specific, and compendial requirements across operations
  • Promote quality culture and continuous improvement through cross-functional communication and advocacy

Requirements

  • Bachelor's degree plus 3 years pharmaceutical industry experience with 1 year direct QA role
  • Or Associate degree plus 4 years pharmaceutical experience with 2 years direct QA role
  • Minimum 1 year batch record review and on-floor quality assurance manufacturing support
  • Ability to handle and manipulate objects using hands and arms
  • Knowledge of cGMP regulations and compendial requirements
  • Experience with standard operating procedures and quality documentation
Vacancy posted a month ago
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