Pharma GMP Auditor - Senior Compliance & CAPA Lead

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

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.