Sr. Auditor

Job Description

Job Title :   Sr. Auditor

Work Location :   Paramus, NJ

Work Type : Onsite

Work Authorization :   Only GC / US Citizens

About the Role :

The RPT QA Auditor is responsible for planning, conducting, and reporting internal and external audits to ensure compliance with current Good Manufacturing Practices (cGMP) , regulatory requirements, and company quality standards. This role plays a key part in strengthening the Pharmaceutical Quality System (PQS) by identifying compliance gaps, recommending corrective actions, and driving continuous improvement across manufacturing, testing, and distribution activities.

Key Responsibilities :

• Plan, schedule, and conduct routine, for-cause, and risk-based audits of internal departments, contract manufacturers (CMOs), and suppliers.
• Develop detailed audit plans, checklists, and audit schedules based on risk assessment and regulatory focus areas.
• Ensure compliance with FDA, EMA, ICH, and other applicable global regulatory guidelines .
• Review and approve deviations, CAPAs, and change controls to ensure timely and effective resolution.
• Document audit observations, issue formal audit reports, and communicate findings to stakeholders.
• Track and verify implementation and effectiveness of corrective and preventive actions (CAPAs).
• Provide guidance and training to internal teams on audit readiness and compliance requirements.
• Support regulatory inspections and customer audits as required.
• Identify systemic quality issues and recommend process improvements across the PQS.
• Stay current on emerging regulatory expectations and industry best practices in radio pharmaceutical manufacturing and quality assurance.

Required Skills & Qualifications :

Preferred Skills :

Why Join Us :

Requirements

cGMP, GDP, FDA, EMA, ICH, RPT cGMP, regulatory inspections, customer audits, CAPA, deviations, change controls, audit planning, audit checklists, audit schedules, audit reporting, process improvements, compliance requirements, audit readiness, report