Senior QA Auditor – Clinical Compliance & GCP Expert

Regulatory Jobs; New Jersey; Ibrido; USD 94.000 - 152.000; Tempo pieno

Vantaggi offerti da questo lavoro

Vacation 120 hours

Sick time 40 hours

Holiday pay

Parental Leave

Bereavement Leave

Volunteer Leave

Military Spouse Time-Off

Descrizione del lavoro

Johnson & Johnson is seeking a Senior Specialist, Quality Assurance Clinical Auditor to join our Quality Organization. The role supports GCP QA audits across multiple sites in Titusville, NJ; Raritan, NJ; Horsham, PA; Spring House, PA; Irvine, CA; or La Jolla, CA.

This hybrid position requires 3 days per week on-site at a listed site. The ideal candidate has 5+ years in auditing/clinical operations, strong knowledge of GCP and regulatory standards, and experience with risk-based audit approaches

Competenze

• Minimum of a Bachelor's degree is required.
• 5+ years of related work experience in auditing, clinical operations, or related area.
• Knowledge of the drug development process and regulatory guidelines (FDA, EU CTR, ICH E6 R2).
• Experience conducting Clinical Quality Assurance audits or assessments of clinical sites/systems.

Mansioni

• Lead planning, conduct and reporting of GCP QA audits (routine and non-routine).
• Ensure audit tools and plans are applied correctly.
• Analyze data and identify patterns/trends in datasets.
• Manage CAPAs and actions from audits.
• Present information clearly in reports and verbally.
• Support QA risk-based auditing approach and audit plans.

Conoscenze

GCP Audits

Regulatory Knowledge

Auditing Experience

Data Analytics

Communication

Time Management

Formazione

Bachelor's degree

Descrizione del lavoro

Johnson & Johnson is seeking a Senior Specialist, Quality Assurance Clinical Auditor to join our Quality Organization. The role supports GCP QA audits across multiple sites in Titusville, NJ; Raritan, NJ; Horsham, PA; Spring House, PA; Irvine, CA; or La Jolla, CA.

This hybrid position requires 3 days per week on-site at a listed site. The ideal candidate has 5+ years in auditing/clinical operations, strong knowledge of GCP and regulatory standards, and experience with risk-based audit approaches