SAN R&D Business Solutions
Job Title:
Sr. Auditor
Work Location:
Paramus, NJ
Work Type:
Onsite
Work Authorization:
Only GC / US Citizens
About the Role The RPT QA Auditor is responsible for planning, conducting, and reporting internal and external audits to ensure compliance with
current Good Manufacturing Practices (cGMP) , regulatory requirements, and company quality standards. This role plays a key part in strengthening the
Pharmaceutical Quality System (PQS)
by identifying compliance gaps, recommending corrective actions, and driving continuous improvement across manufacturing, testing, and distribution activities.
Key Responsibilities
Plan, schedule, and conduct
routine, for-cause, and risk-based audits
of internal departments, contract manufacturers (CMOs), and suppliers.
Develop detailed
audit plans, checklists, and audit schedules
based on risk assessment and regulatory focus areas.
Ensure compliance with
FDA, EMA, ICH, and other applicable global regulatory guidelines .
Review and approve
deviations, CAPAs, and change controls
to ensure timely and effective resolution.
Document audit observations, issue formal audit reports, and communicate findings to stakeholders.
Track and verify
implementation and effectiveness
of corrective and preventive actions (CAPAs).
Provide
guidance and training
to internal teams on audit readiness and compliance requirements.
Support
regulatory inspections
and customer audits as required.
Identify
systemic quality issues
and recommend process improvements across the PQS.
Stay current on
emerging regulatory expectations
and industry best practices in radio pharmaceutical manufacturing and quality assurance.
Required Skills & Qualifications
Bachelor’s degree
in Life Sciences, Pharmacy, or a related scientific field.
3–5 years
of experience in
Radio Pharmaceuticals , including at least
2 years in auditing
or QA compliance.
Strong knowledge of
RPT cGMP ,
GDP , and relevant
global regulatory requirements .
Excellent attention to detail, analytical thinking, and problem-solving skills.
Strong
written and verbal communication
skills, with the ability to prepare clear audit reports.
Ability to travel up to
10%
for on-site audits and supplier visits.
Preferred Skills
ASQ Certified Quality Auditor (CQA)
certification.
ISO 9001 Lead Auditor
certification.
GCP/GMP auditing certifications
or equivalent regulatory compliance training.
Why Join Us
Opportunity to work in a
highly regulated and growing sector
of Radio Pharmaceuticals.
Collaborate with a
mission-driven team
focused on patient safety, compliance, and quality excellence.
Gain exposure to
global quality systems
and diverse manufacturing and supplier environments.
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Sr. Auditor
Work Location:
Paramus, NJ
Work Type:
Onsite
Work Authorization:
Only GC / US Citizens
About the Role The RPT QA Auditor is responsible for planning, conducting, and reporting internal and external audits to ensure compliance with
current Good Manufacturing Practices (cGMP) , regulatory requirements, and company quality standards. This role plays a key part in strengthening the
Pharmaceutical Quality System (PQS)
by identifying compliance gaps, recommending corrective actions, and driving continuous improvement across manufacturing, testing, and distribution activities.
Key Responsibilities
Plan, schedule, and conduct
routine, for-cause, and risk-based audits
of internal departments, contract manufacturers (CMOs), and suppliers.
Develop detailed
audit plans, checklists, and audit schedules
based on risk assessment and regulatory focus areas.
Ensure compliance with
FDA, EMA, ICH, and other applicable global regulatory guidelines .
Review and approve
deviations, CAPAs, and change controls
to ensure timely and effective resolution.
Document audit observations, issue formal audit reports, and communicate findings to stakeholders.
Track and verify
implementation and effectiveness
of corrective and preventive actions (CAPAs).
Provide
guidance and training
to internal teams on audit readiness and compliance requirements.
Support
regulatory inspections
and customer audits as required.
Identify
systemic quality issues
and recommend process improvements across the PQS.
Stay current on
emerging regulatory expectations
and industry best practices in radio pharmaceutical manufacturing and quality assurance.
Required Skills & Qualifications
Bachelor’s degree
in Life Sciences, Pharmacy, or a related scientific field.
3–5 years
of experience in
Radio Pharmaceuticals , including at least
2 years in auditing
or QA compliance.
Strong knowledge of
RPT cGMP ,
GDP , and relevant
global regulatory requirements .
Excellent attention to detail, analytical thinking, and problem-solving skills.
Strong
written and verbal communication
skills, with the ability to prepare clear audit reports.
Ability to travel up to
10%
for on-site audits and supplier visits.
Preferred Skills
ASQ Certified Quality Auditor (CQA)
certification.
ISO 9001 Lead Auditor
certification.
GCP/GMP auditing certifications
or equivalent regulatory compliance training.
Why Join Us
Opportunity to work in a
highly regulated and growing sector
of Radio Pharmaceuticals.
Collaborate with a
mission-driven team
focused on patient safety, compliance, and quality excellence.
Gain exposure to
global quality systems
and diverse manufacturing and supplier environments.
#J-18808-Ljbffr