Remote GMP Auditor

Intertek•United States,

8h•Remote

About The Position

Intertek is seeking a Pharmaceutical, Dietary Supplement and Cosmetic GMP Auditor to join their Remote Business Assurance team. This role involves performing GMP compliance supplier audits to ensure clients' products are manufactured, tested, handled, and stored in compliance with FDA or other country-specific regulations and client requirements. The position requires significant travel, at least 50% to 75% of the time. Intertek's Business Assurance team focuses on ensuring the success of client companies and their products through assurance solutions that provide confidence in operating procedures, systems, and people.

Requirements

Bachelor’s Degree in Chemistry, Biology, Engineering or related scientific field.
Experience may be substituted for Bachelor’s degree: Associate degree plus minimum of 2 years pharmaceutical manufacturing, packaging, or laboratory experience; or High School diploma/GED plus minimum of 6 years pharmaceutical manufacturing, packaging, or laboratory experience.
Valid driver’s license and reliable driving record is required.
Routine demands of an office-based environment.
Applicants must reside in and be able to legally work in the United States.

Nice To Haves

Quality Auditor certification
A minimum of 5 years actively participating in a GMP lead auditor role; supplier auditing experience
Previous project management experience working in an ATIC environment is an advantage.

Responsibilities

Plan, prepare, and conduct facility audits in support of GMP.
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 evaluate potentially critical problems.
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 regulated processes (manufacturing, testing) comply 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.
Communicate audit results to management and auditees through written audit reports.
Draft and Submit Audit Report for internal review.
Manage post-audit activities (e.g.: CAPA assessment and review) and follow up on any necessary corrective and preventive actions by resolving any conflicts.
Manage and ensure all travel arrangements are in compliance with applicable travel policies.
Maintain current knowledge of industry standards and expectations.