Remote GMP Auditor

Intertek•Arlington Heights, IL

11d•Remote

About The Position

Intertek, a leading provider of quality and safety solutions, is seeking a Pharma, 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 applicable FDA or other country-specific regulations and client-specific requirements. The Business Assurance team focuses on the underlying elements that contribute to a company's and its products' success, offering assurance solutions that provide confidence in operating procedures, systems, and people. Intertek aims to reduce risk for consumers, brands, and organizations across all sectors and industries.

Requirements

Accredited Quality Auditor Certification through ASQ, ANAB, IRCA or other recognized auditor training body meeting ISO/IEC 17021 (for management system certification bodies) or ISO/IEC 17065 (for product/process certification bodies).
A four-year college/university degree in a science or technical field (biology or microbiology; chemistry or biochemistry; computer and software technology; electrical, electronic, mechanical or bioengineering; human physiology; medicine; pharmacy; physics or biophysics) or equivalent combination of relevant education and work experience.
Minimum of two-years experience in GMP industry environment (Manufacturing, CAPA, Auditing, Complaint Review).
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

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 not covered by existing guidelines.
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 (e.g., 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 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.