[Hiring] GMP Auditor @Intertek

Role Description

Intertek, a leading provider of quality and safety solutions, is actively seeking a Pharma, Dietary Supplement and Cosmetic GMP Auditor to join our Remote Business Assurance team. This is a full-time position, primarily responsible for performing GMP compliance supplier audits to ensure that client’s products are manufactured, tested, handled, and stored in compliance with applicable FDA or other country-specific regulations and client-specific requirements. This position will require travel at least 50% to 75% of the time.

What you’ll do:

• 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 evaluate 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 regulated processes are in compliance with applicable regulations and guidelines.
• 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.
• Manage and ensure all travel arrangements are in compliance with applicable travel policies.
• Maintain current knowledge of industry standards and expectations.

Qualifications

• Accredited Quality Auditor Certification through ASQ, ANAB, IRCA or other recognized auditor training body.
• A four-year college/university degree in a science or technical field 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.
• This is a remote position; however, applicants must reside in and be able to legally work in the United States.

Preferred Requirements & Qualifications

• 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.

Physical Requirements

• Ascend or descend ladders, stairs, ramps, and the like, using feet and legs and/or hands and arms.
• Stand for sustained periods of time.
• Walk to accomplish tasks and to move from one work location to another.
• Communicate well, through spoken word, conveying detailed accurate information & instructions to others.
• Hear well, perceiving sounds with or without correction.
• Exert up to 10 pounds of force occasionally and/or negligible amounts of force frequently to lift, carry, push, pull or otherwise move objects.
• Have close visual acuity to perform activities such as preparing & analyzing data, viewing a computer monitor, reading, report writing, and visual inspection.

Salary & Benefits Information

• Competitive compensation packages based on skill set, experience, qualifications, and other job-related reasons.
• Benefits including medical, dental, vision, life, disability, 401(k) with company match, generous vacation/sick time (PTO), tuition reimbursement, and more.