What are the responsibilities and job description for the Senior Auditor position at Arigo HR Solutions?
Position: RPT QA Auditor
Location: Paramus, NJ, USA
Employment Type: Contract – Onsite
Job Summary
We are seeking an experienced RPT QA Auditor responsible for planning, conducting, and reporting on internal and external audits to ensure compliance with cGMP, regulatory requirements, and company quality standards. This role plays a key part in supporting the Pharmaceutical Quality System (PQS) by identifying compliance gaps, recommending corrective actions, and driving continuous improvement across manufacturing, testing, and distribution processes.
Key Responsibilities
- Conduct routine, for-cause, and risk-based audits of internal processes, RPT CMOs, and suppliers.
- Prepare detailed audit plans, checklists, and schedules.
- Ensure adherence to FDA, EMA, ICH, and other relevant regulatory guidelines.
- Review and approve deviations, CAPAs, and change controls.
- Document audit observations and issue formal audit reports.
- Track and verify implementation of corrective and preventive actions (CAPAs).
- Provide guidance on compliance requirements and audit readiness.
- Support regulatory inspections and customer audits.
- Identify systemic issues and recommend process improvements.
- Stay updated on evolving regulatory requirements and industry best practices.
Qualifications
- Bachelor’s degree in Life Sciences, Pharmacy, or related field.
- 3–5 years of experience in Radiopharmaceuticals, including at least 2 years in auditing.
- Strong knowledge of RPT cGMP, GDP, and global regulatory requirements.
- Excellent attention to detail and analytical skills.
- Strong communication and report-writing abilities.
- Willingness to travel (up to 10%) for audits.
Preferred Certifications
- ASQ Certified Quality Auditor (CQA)
- ISO 9001 Lead Auditor
- GCP/GMP auditing certifications
