Radio Pharmaceuticals QA Auditor
6 days ago
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: Bachelor's degree in Life Sciences, Pharmacy, or related field. 3–5 years in Radio Pharmaceuticals (Must Have) , 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 #J-18808-Ljbffr
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Auditor
6 days ago
Paramus, United States Kelli Global Full timeBase pay range: $60.00/hr - $67.00/hr 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...
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GMP Senior Auditor
2 weeks ago
Paramus, United States Katalyst HealthCares & Life Sciences Full timeJob Description: Must Have Radiopharmaceuticals and Quality experience. All others will not be considered. 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)...
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GMP Senior Auditor
5 days ago
Paramus, United States Katalyst HealthCares & Life Sciences Full timeJob Description Must Have Radiopharmaceuticals and Quality experience. All others will not be considered. 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)...
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GMP Senior Auditor
5 days ago
Paramus, United States Katalyst Healthcares and Life Sciences Full timeJob Description Must Have Radiopharmaceuticals and Quality experience. ll others will not be considered. *** 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...
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Sr. Auditor
7 days ago
Paramus, NJ, United States 5 Star Global Recruitment Partners Full timeAbout 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...
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GMP Sr. Auditor Paramus, NJ
5 days ago
Paramus, United States ESRhealthcare Full timeOverview GMP Sr. Auditor Paramus, NJ 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: No Job Summary: The RPT QA Auditor is responsible for...
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Sr. Auditor
5 days ago
Paramus, United States Global Channel Management Full timeJob description About the job Sr. Auditor Sr. Auditor needs 35 years in Radio Pharmaceuticals, with at least 2 years in auditing. Sr. Auditor requires: 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,...
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Senior Radiopharma QA Auditor
5 days ago
Paramus, United States Katalyst HealthCares & Life Sciences Full timeA prominent healthcare company in Paramus, New Jersey, is looking for an RPT QA Auditor to ensure compliance with cGMP and regulatory requirements. The role involves conducting audits, preparing plans, and tracking corrective actions in pharmaceutical manufacturing processes. The ideal candidate should possess a degree in Life Sciences or Pharmacy, strong...
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GMP Senior Auditor
2 weeks ago
Paramus, NJ, United States Katalyst Healthcares and Life Sciences Full timeJob Description: Must Have Radiopharmaceuticals and Quality experience. ll others will not be considered. *** 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...
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GMP Senior Auditor
2 weeks ago
Paramus, NJ, United States Katalyst Healthcares and Life Sciences Full timeJob Description: Must Have Radiopharmaceuticals and Quality experience. ll others will not be considered. *** 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...