Sr. Auditor

Job Description

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 :