Internal Compliance Auditor

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Manufacturing Quality & Reg.

- 213 Full-time Regular FULL TIME Remote, Boca Raton, FL, US

2 days ago Requisition

Salary Range: $70,000.00 To $90,000.00 Annually

Internal Compliance Auditor

Job Description

Reporting to:Supplier Quality Assurance Manager

Key Responsibilities

• Plan, organize, and manage internal and supplier audit schedules (as applicable), ensuring they are aligned with both company and regulatory requirements.
• Oversee the execution of internal GMP (21 CFR 212) and external audits (as applicable), ensuring audits are conducted in a thorough and consistent manner.
• Review and approve audit reports, ensuring that findings are clearly documented, supported by evidence, and aligned with internal and regulatory requirements.
• Monitor the follow-up of audit findings, ensuring that corrective and preventive actions are implemented effectively and in a timely manner.
• Ensure proper documentation and archiving of all audit reports, evidence, and follow-up activities.
• Collaborate with relevant departments to address audit findings, improve processes, and foster a culture of continuous improvement.
• Stay updated on changes in regulatory requirements and industry best practices for auditing.
• Develop and provide training sessions for internal teams on audit performance, preparedness, and quality standards.
• Analyze audit results and trends to identify areas for systemic improvement and report these insights to senior management.
• Represent the QA department in cross-functional meetings related to audit findings, strategies, and improvements.
• Engage in travel as required for supplier or site audits, as well as for professional development or industry conferences.
• Other duties as required by management.
• Bachelor’s degree in fields such as Biology, Chemistry, Pharmaceutical Sciences, or a related scientific discipline. A degree in Business Administration or Accounting can also be relevant if combined with industry-specific experience.
• ASQ Certified Quality Auditor (CQA) required or equivalent.
• Multiple years of experience in quality assurance auditing, specifically within the pharmaceutical or 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.

About Us

Pharma Logic is the fastest-growing contract development and manufacturing organization (CDMO) and radiopharmaceutical solutions provider, dedicated to nuclear medicine and radiopharmaceutical production. With over 1,000 team members and a vast network of radio pharmacies, we reach patients across North America and are committed to reinvesting in the industry to improve as many lives as possible.

Our Philosophy

We are passionate about expanding the power of radiopharmaceutical technology to bring transformative diagnostic and therapeutic agents to patients from bench to bedside.