Remote GMP Auditor

About the role

Intertek is a leading provider of quality and safety solutions, seeking a Pharma, Dietary Supplement and Cosmetic GMP Auditor to join its Remote Business Assurance team. The role involves performing GMP compliance supplier audits to ensure client products are manufactured, tested, handled, and stored in accordance with FDA or other country‑specific regulations and client requirements. This is a full‑time remote position (candidates must reside and be legally authorized to work in the United States) with travel expected 50%–75% of the time.

Responsibilities

• Plan, prepare, and conduct facility audits in support of GMP as directed.
• Create Audit Plans and Agendas, and send to site;
• Hold Opening and Closing Meetings;
• Interview and observe operations in situ.
• Assemble and coordinate the activities of the audit team.
• Interpret policies, standards, and regulations, and then evaluates potentially critical problems not covered by policies, standards, and regulations.
• Assess compliance with applicable FDA, or country specific regulations and guidelines, and/or the client’s requirements and specifications.
• Advise office immediately of any critical observations identified during audit.
• Ensure that written procedures are followed, and exercise judgment in evaluating quality systems, processes, procedures, and protocols for compliance.
• Review SOPs to ensure procedures and systems used in the regulated processes, such as manufacturing and testing, are in compliance with applicable regulations and guidelines, including documented procedures for OOS, recalls, deviations, complaints, CAPA, QA responsibilities, batch record review and batch disposition.
• Appropriately escalate any compliance issues.