GMP Sr. Auditor Paramus, NJ

ESR Healthcare; Paramus (NJ); On-site; USD 61,992 - 82,656; Full time

Job summary

A leading healthcare firm in Paramus, NJ is seeking a GMP Sr. Auditor. This role is responsible for conducting and reporting on internal and external audits to ensure regulatory compliance and quality standards. The ideal candidate will hold a Bachelor’s degree in a related field and have 3–5 years of experience in Radio Pharmaceuticals, including auditing. Strong analytical skills and attention to detail are essential, along with the ability to travel for audits.

Qualifications

• 3–5 years in Radio Pharmaceuticals, with at least 2 years in auditing.
• Strong knowledge of RPT cGMP, GDP, and global regulatory requirements.
• Ability to travel (up to 10%) for audits.

Responsibilities

• Conduct routine, for-cause, and risk-based audits of internal processes.
• Prepare detailed audit plans, checklists, and schedules.
• Document audit observations and issue formal audit reports.

Skills

Attention to detail

Analytical skills

Communication

Report writing

Education

Bachelor’s degree in Life Sciences, Pharmacy, or related field

Job description

GMP Sr. Auditor

Location: Paramus, NJ

Job Details

• Experience level: Mid-senior
• Experience required: 5 Years
• Education level: Bachelor’s degree
• Job function: Accounting/Auditing
• Industry: Pharmaceuticals
• Pay rate: View hourly payrate
• Total position: 1
• Relocation assistance: No
• Visa sponsorship eligibility: No

Job Summary

The RPT QA Auditor is responsible for planning, conducting, and reporting on internal and external audits to ensure compliance with cGMP, regulatory requirements, and company quality standards. This role supports the Pharmaceutical Quality System (PQS) by identifying 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 applicable 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 in Radio Pharmaceuticals, with 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.
• Ability to travel (up to 10%) for audits.

Preferred Certifications

• ASQ Certified Quality Auditor (CQA)
• ISO 9001 Lead Auditor
• GCP/GMP auditing certifications