GMP Sr. Auditor Paramus, NJ

1 week ago

Paramus, NJ, United States ESR Healthcare Full time

About the job GMP Sr. Auditor Paramus, NJ

GMP Sr. Auditor Paramus, NJ

Experience level: Mid-senior Experience required: 5 Years Education level: Bachelors 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:

Bachelors degree in Life Sciences, Pharmacy, or related field.
35 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

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