Senior QA Auditor – GMP/GDP (On-Site Paramus, NJ)

globalplacementfirm; Paramus (NJ); On-site; USD 83,000 - 124,000; Full time

Job summary

globalplacementfirm seeks a Senior Quality Assurance Auditor in Paramus, NJ for a 5-month on-site contract. The role focuses on planning, conducting, and reporting audits to ensure GMP/GDP compliance and PQS readiness across operations.

The successful candidate will bring 5+ years in pharmaceutical QA and experience auditing suppliers, CMOs, and internal processes, with travel up to 10%.

Qualifications

• 5+ years of pharmaceutical QA experience, incl. audits.
• Bachelor's in Life Sciences or related field.
• GMP, GDP, and radiopharmaceutical compliance knowledge.
• FDA/EMA/ICH regulatory familiarity.
• 10% travel for domestic or international audits.

Responsibilities

• Conduct internal audits, supplier audits, and CMO audits including routine and for-cause.
• Develop and manage audit plans, schedules, and checklists.
• Assess compliance with FDA, EMA, ICH and GMP/GDP regulations.
• Review deviations, CAPAs, and change control records.
• Generate detailed audit reports and communicate findings.
• Track CAPA implementation and verification of effectiveness.
• Support regulatory inspections and third-party audits.
• Provide expertise on quality/compliance and audit readiness.
• Identify systemic gaps and drive continuous improvement.
• Stay current on regulatory changes and industry trends.

Skills

Auditing

Quality Assurance

Regulatory compliance

Documentation

Analytical skills

Travel readiness

FDA/EMA/ICH knowledge

Education

Bachelor's degree in Life Sciences or related

Job description

globalplacementfirm seeks a Senior Quality Assurance Auditor in Paramus, NJ for a 5-month on-site contract. The role focuses on planning, conducting, and reporting audits to ensure GMP/GDP compliance and PQS readiness across operations.

The successful candidate will bring 5+ years in pharmaceutical QA and experience auditing suppliers, CMOs, and internal processes, with travel up to 10%.