Quality Assurance Auditor

#Hiring: GCP Quality Assurance Auditor

Location: Paramus, NJ

Pay Rate: $55+/hr

Schedule: Contract Hybrid (3 days onsite, 2 days remote)

The GCP Quality Assurance Auditor will ensure GXP compliance with regulatory authorities, support quality management systems, and conduct internal and external audits in clinical operations, non-clinical, and manufacturing. The role supports clinical trials by managing CROs, CMOs, investigator sites, and vendors, providing day-to-day support to the GXP QA Director.

Key Responsibilities

Plan and conduct global clinical process and vendor audits across all trials

Conduct audits based on risk for specific clinical processes

Perform vendor audits with SMEs (IRT, EDC, etc.) to assess services provided

Develop and distribute audit reports to stakeholders

Manage related clinical vendor non-conformances

Review and audit clinical regulations and guidelines (FDA, GCP, etc.)

Collaborate with clinical sourcing, supplier quality, and partnerships to manage vendors

Support regulatory agency inspections preparation and participation

Participate in quality improvement projects

Qualifications & Requirements

BS degree in scientific, healthcare, or related discipline

5+ years pharmaceutical experience

2+ years RadioPharmaceutical and QA experience

Intensive GCP and safety background

Experience with internal and external audits

Knowledge of SOPs, QMS, and development policies/procedures

Ability to work with global teams on audit objectives

10% travel required