GMP Sr. Auditor Paramus, NJ at ESRhealthcare

GMP Sr. Auditor Paramus NJ If you post this job on a job board please do not use company name or salary. Experience level: Mid-senior Experience required: 5 Years Education level: Bachelors degree Job function: Accounting/Auditing Industry: Pharmaceuticals Pay rate : View hourly payrate Total position: 1 Relocation assistance: No Visa sponsorship eligibility: NoJob 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 AuditorGCP/GMP auditing certifications Key Skills Auditing,Time Management,ICD-10,Accounting,Component evaluation,Workers' Compensation Law,SOX,Microsoft Excel,CPT Coding,Internal Audits,Medicare,Bookkeeping Employment Type : Full Time Experience: years Vacancy: 1