Radio Pharmaceuticals QA Auditor

BioHire Health; Paramus (NJ); On-site; USD 70,000 - 100,000; Full time

Job summary

A leading healthcare organization in New Jersey is seeking an RPT QA Auditor responsible for planning and conducting audits to ensure compliance with regulatory requirements. This role requires a Bachelor's degree and 3–5 years of experience in Radio Pharmaceuticals, with expertise in cGMP and auditing. Candidates should possess strong analytical abilities and communication skills, 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.
• Ensure adherence to FDA, EMA, ICH, and other regulatory guidelines.
• Review and approve deviations, CAPAs, and change controls.
• Document audit observations and issue formal audit reports.

Skills

Attention to detail

Analytical skills

Strong communication

Report-writing abilities

Education

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

Job description

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 (Must Have) , 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