5 Star Recruitment

Sr. Auditor

5 Star Recruitment·Paramus, New Jersey, US

Projected AI Stack

Based on our analysis of Accountants and Auditors positions

7.5Very High AI Upgrade Potential
MCMicrosoft 365 CopilotSOC audit workpaper documentation and evidence tracking spreadsheetsdaily
CLClaudeDraft audit findings summaries and compliance gap analysis memosweekly
PXPerplexityResearch FedRAMP, FISMA, and DoD policy updates for examination scopeweekly

Projected Workflow

How AI is expected to reshape this role

AI-assisted

Audit evidence collection and documentationMicrosoft 365 Copilot
Compliance findings summarization and reportingClaude
Regulatory framework research and benchmarkingPerplexity

Human-led

External auditor liaison and SOC1 coordination
Internal control evaluation and walkthroughs
Risk assessment and audit scoping
Audit opinion review and final sign-off

This AI stack and workflow map are projected by UpgradedJobs based on occupational analysis, not stated by the employer. They reflect how AI tools are transforming Accountants and Auditors roles today.

About the role


Sr. Auditor

Paramus, New Jersey, United States

About the Job Sr. Auditor

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:

  • Bachelors 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.

Preferred Certifications:

  • ASQ Certified Quality Auditor (CQA)
  • ISO 9001 Lead Auditor
  • GCP/GMP auditing certifications

Or refer someone

Interested in this role?

Apply on 5 Star Recruitment website →

Listed on UpgradedJobs · Originally posted on Recruit.net

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