Senior QA Auditor Radiopharmaceuticals

Paramus, NJ - USA

Monthly Salary: Not Disclosed

Posted on: 30+ days ago

Vacancies: 1 Vacancy

Job Summary

We are seeking an experienced Senior QA Auditor with a strong background in Radiopharmaceuticals (RPT) to join our quality assurance team. This role plays a critical part in ensuring compliance with cGMP GDP FDA EMA and ICH regulatory standards while supporting the Pharmaceutical Quality System (PQS) through proactive auditing and continuous improvement initiatives.

The ideal candidate is a detail-oriented professional with hands-on experience conducting internal and external audits across manufacturing testing and distribution operations.

Key Responsibilities

Plan conduct and report on internal external and risk-based audits of RPT CMOs suppliers and internal processes.
Develop comprehensive audit plans checklists and schedules in alignment with regulatory and company standards.
Ensure strict adherence to FDA EMA ICH and other relevant global compliance frameworks.
Review and approve deviations CAPAs and change controls ensuring effective closure and documentation.
Issue detailed audit reports and maintain oversight of CAPA implementation and verification.
Guide operational teams on audit readiness and compliance requirements.
Support regulatory inspections and customer audits ensuring seamless coordination and documentation.
Identify systemic quality issues and contribute to the development of process improvement initiatives.
Stay informed on evolving global quality and regulatory standards to maintain audit program effectiveness.

Qualifications (Must Have)

Bachelors degree in Life Sciences Pharmacy or a related discipline.
35 years of experience in Radiopharmaceuticals with a minimum of 2 years in auditing.
In-depth knowledge of RPT cGMP GDP and global regulatory requirements.
Proven ability to plan execute and report audits independently.
Strong analytical organizational and report-writing skills.
Excellent communication skills and attention to detail.
Ability to travel up to 10% for audits and inspections.

Preferred / Nice to Have

ASQ Certified Quality Auditor (CQA).
ISO 9001 Lead Auditor Certification.
GCP/GMP Auditing Certifications or equivalent industry credentials.

Core Competencies & Technical Skills

cGMP GDP FDA EMA ICH RPT cGMP
Regulatory Inspections Customer Audits CAPA Deviations Change Controls
Audit Planning Checklists Scheduling Reporting Process Improvements
Compliance Requirements Audit Readiness Report Writing PQS ISO 9001
Excellent Analytical & Communication Skills

We are seeking an experienced Senior QA Auditor with a strong background in Radiopharmaceuticals (RPT) to join our quality assurance team. This role plays a critical part in ensuring compliance with cGMP GDP FDA EMA and ICH regulatory standards while supporting the Pharmaceutical Quality System (PQS...

The ideal candidate is a detail-oriented professional with hands-on experience conducting internal and external audits across manufacturing testing and distribution operations.

Key Responsibilities

Plan conduct and report on internal external and risk-based audits of RPT CMOs suppliers and internal processes.
Develop comprehensive audit plans checklists and schedules in alignment with regulatory and company standards.
Ensure strict adherence to FDA EMA ICH and other relevant global compliance frameworks.
Review and approve deviations CAPAs and change controls ensuring effective closure and documentation.
Issue detailed audit reports and maintain oversight of CAPA implementation and verification.
Guide operational teams on audit readiness and compliance requirements.
Support regulatory inspections and customer audits ensuring seamless coordination and documentation.
Identify systemic quality issues and contribute to the development of process improvement initiatives.
Stay informed on evolving global quality and regulatory standards to maintain audit program effectiveness.

Qualifications (Must Have)

Bachelors degree in Life Sciences Pharmacy or a related discipline.
35 years of experience in Radiopharmaceuticals with a minimum of 2 years in auditing.
In-depth knowledge of RPT cGMP GDP and global regulatory requirements.
Proven ability to plan execute and report audits independently.
Strong analytical organizational and report-writing skills.
Excellent communication skills and attention to detail.
Ability to travel up to 10% for audits and inspections.