Sr. Auditor

Globalchannelmanagement; Paramus (NJ); On-site; USD 80,000 - 120,000; Full time

Job summary

A leading company in pharmaceuticals is looking for a Sr. Auditor based in Paramus, NJ. The ideal candidate should have extensive experience in Radio Pharmaceuticals and auditing, along with knowledge of cGMP, FDA, EMA, and ICH regulations. Strong analytical skills and the ability to conduct various audits are essential. This role involves preparing audit plans, tracking corrective actions, and supporting regulatory inspections. A Bachelor’s degree in a relevant field and ASQ Certification are required.

Qualifications

• 35 years in Radio Pharmaceuticals.
• At least 2 years in auditing.
• Ability to travel (up to 10%) for audits.
• Strong knowledge of RPT cGMP, GDP, and global regulatory requirements.
• Excellent attention to detail and analytical skills.
• Strong communication and report-writing abilities.
• ASQ Certified Quality Auditor (CQA).

Responsibilities

• Conduct routine, for-cause, and risk-based audits.
• 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.
• Track and verify implementation of corrective and preventive actions (CAPAs).
• Provide guidance on compliance requirements and audit readiness.
• Support regulatory inspections and customer audits.

Skills

cGMP

GDP

FDA

EMA

ICH

RPT cGMP

regulatory inspections

customer audits

CAPA

deviations

change controls

audit planning

audit checklists

audit schedules

audit reporting

process improvements

compliance requirements

audit readiness

report writing

analytical skills

communication skills

pharmaceutical quality system (PQS)

ISO 9001

GCP

GMP

ASQ Certified Quality Auditor (CQA)

Education

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

Job description

Sr. Auditor needs 35 years in Radio Pharmaceuticals, with at least 2 years in auditing.

Sr. Auditor requires:

Skills: cGMP, GDP, FDA, EMA, ICH, RPT cGMP, regulatory inspections, customer audits, CAPA, deviations, change controls, audit planning, audit checklists, audit schedules, audit reporting, process improvements, compliance requirements, audit readiness, report writing, analytical skills, communication skills, pharmaceutical quality system (PQS), auditing, ISO 9001, GCP, GMP, ASQ Certified Quality Auditor (CQA)

• Bachelors degree in Life Sciences, Pharmacy, or related field.
• 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.
• ASQ Certified Quality Auditor (CQA)
• 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.