Remote GMP Auditor

About the role

This is a full-time position, with the person primarily responsible for performing GMP compliance supplier audits to assure that client’s products have been manufactured, tested, handled and stored in compliance with applicable FDA or other country specific regulations and client specific requirements. This position will travel at least 50% to 75% of the time.

Responsibilities

• Plan, prepare, and conduct of 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 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 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.
• 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.

Qualifications

• 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.

Preferred Requirements & Qualifications

• 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.

Pay

Individual compensation packages are based on a variety of factors unique to each candidate including skill set, experience, qualifications, and other job-related reasons. In addition to competitive compensation packages, when working with Intertek you can expect benefits including medical, dental, vision, life, disability, 401(k) with company match, generous vacation / sick time (PTO), tuition reimbursement and more.

Schedule

This is a remote position; however, applicants must reside in and be able to legally work in the United States.

Benefits

In addition to competitive compensation packages, when working with Intertek you can expect benefits including medical, dental, vision, life, disability, 401(k) with company match, generous vacation / sick time (PTO), tuition reimbursement and more.

About Intertek

Intertek is a leading Total Quality Assurance provider to industries worldwide. Our network of more than 1,000 laboratories and offices in more than 100 countries, delivers innovative and bespoke Assurance, Testing, Inspection and Certification (ATIC) solutions for our customers' operations and supply chains. Working at Intertek means joining a global network of state-of-the-art facilities and passionate people who deliver superior customer service with a purpose of bringing quality, safety, and sustainability to life.