Internal Compliance Auditor

PharmaLogic•Boca Raton, FL

4h•$70,000 - $90,000

About The Position

The Internal Compliance Auditor plans and manages internal and supplier audit schedules, oversees internal GMP (21 CFR 212) and external audits, and ensures audit reports and supporting evidence meet company and regulatory requirements. The role monitors corrective and preventive actions, maintains audit documentation, and works with departments to resolve findings and improve processes. It also tracks regulatory and industry developments, provides audit-related training, analyzes trends for systemic improvement, and represents Quality Assurance in cross-functional discussions. Travel is required for supplier or site audits and may also involve professional development or industry conferences; the position indicates 75% travel.

Requirements

Bachelor’s degree in Biology, Chemistry, Pharmaceutical Sciences, or a related scientific discipline; a Business Administration or Accounting degree may be relevant when combined with industry-specific experience.
ASQ Certified Quality Auditor (CQA) certification or equivalent.
Multiple years of quality assurance auditing experience, specifically in the pharmaceutical or a related industry.
Comprehensive knowledge of pharmaceutical industry regulations, including GMPs, ISO standards, FDA guidelines, and other relevant standards.
Strong analytical, organizational, and communication skills.
Ability to handle sensitive information with integrity and confidentiality.

Responsibilities

Plan, organize, and manage internal and supplier audit schedules, aligning them with company and regulatory requirements.
Oversee internal GMP (21 CFR 212) and external audits, as applicable, to ensure thorough and consistent execution.
Review and approve audit reports, ensuring findings are clearly documented, evidence-supported, and aligned with internal and regulatory requirements.
Monitor audit-finding follow-up and ensure corrective and preventive actions are implemented effectively and promptly.
Ensure audit reports, evidence, and follow-up activities are properly documented and archived.
Collaborate with relevant departments to address audit findings, improve processes, and promote continuous improvement.
Stay updated on regulatory requirements and industry best practices for auditing.
Develop and provide training for internal teams on audit performance, preparedness, and quality standards.
Analyze audit results and trends to identify systemic improvement opportunities and report insights to senior management.
Represent the QA department in cross-functional meetings about audit findings, strategies, and improvements.
Travel as required for supplier or site audits, professional development, and industry conferences.
Perform other duties as required by management.