Overview
On Site
Depends on Experience
Contract - W2
Skills
Auditor
pharma
lifescience
healthcare
capa
gmp
iso
Job Details
Role: Sr. Auditor
Location: Paramus, NJ (Onsite)
Duration: 12 Months Contract
Location: Paramus, NJ (Onsite)
Duration: 12 Months Contract
Job Summary:
Key Responsibilities:
Qualifications:
Preferred Certifications:
- 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 RadioPharmaceuticals, 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
- Google Cloud Platform/GMP auditing certifications
Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.