Senior QA Auditor: Drive cGMP Compliance & CAPA Excellence

5 Star Recruitment; Paramus (NJ); On-site; USD 85,000 - 120,000; Full time

Job summary

5 Star Recruitment seeks a RPT QA Auditor to plan, conduct, and report audits ensuring cGMP compliance across manufacturing, testing, and distribution. The role supports the Pharmaceutical Quality System by identifying gaps, recommending corrective actions, and driving continuous improvement.

The position emphasizes adherence to FDA, EMA, and ICH guidelines, review of deviations and CAPAs, and audit readiness. Travel up to 10% for supplier and site audits may be required.

Qualifications

• Bachelor's 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.

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.

Skills

Attention to detail

Analytical skills

Report writing

Communication

Education

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

Job description

5 Star Recruitment seeks a RPT QA Auditor to plan, conduct, and report audits ensuring cGMP compliance across manufacturing, testing, and distribution. The role supports the Pharmaceutical Quality System by identifying gaps, recommending corrective actions, and driving continuous improvement.

The position emphasizes adherence to FDA, EMA, and ICH guidelines, review of deviations and CAPAs, and audit readiness. Travel up to 10% for supplier and site audits may be required.