Radio Pharmaceuticals QA Auditor: Compliance & Improvement

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

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.