Careers at the Planet group

GCP Auditor

Paramus, NJ 07652

Posted: 01/26/2026 Employment Type: Contract Job Category: Scientific Job Number: 642810 Is job remote?: No

Job Description

Job Title: GCP Auditor
Location: Paramus, NJ; Hybrid, onsite 3 days/week (Tue, Wed, & Thu)
Contract length: 2 months
Schedule: 40 hrs/week (8 hrs out of 7:30a to 5p)
Pay: $55/hr to $60/hr, DOE

GCP Auditor Job Overview:
The GCP Quality Assurance Auditor will report to the Director of the GCP/PVG Quality Assurance. This position will be focused on ensuring GXP compliance with regulatory authorities, driving and implementing the Company’s compliance directives and supporting quality management systems to ensure compliance and minimize risk in a regulated pharmaceutical environment. The incumbent will conduct and or participate in all GXP QA audit programs which include both internal and external GXP audits. This position will provide day-to-day support to the GXP QA Director in clinical operations/Non-clinical and Manufacturing to manage CROs, CMOs, investigator sites, and all relevant vendors to support clinical trials. The Auditor of Quality Assurance will work with the QA and cross-functional teams, communicate with QA consultants and has contact with external auditees, vendors, partners and affiliates. The ideal candidate will have extensive GCP experience. This opportunity is with a rapidly growing biopharmaceutical company that specializes in Neurology and Psychiatry therapies. They are based in Northern New Jersey and require the candidate to be on-site. Performs and manages all types of audits in the audit program of Clinical Development and Safety Pharmacovigilance.

GCP Auditor Required Qualifications:
  • 2+ years of relevant radiopharmaceutical experience
  • BS degree in scientific, health care or related discipline
  • Intensive GCP and safety background
  • Experience with both internal and external process and systems audits
  • Strong knowledge of development policies, procedures and standards (SOPs, QMS)
  • Ability to work with global clinical teams in developing objectives for audits of clinical studies
  • 10% travel

GCP Auditor Job Responsibilities:
  • Plan and conduct scheduled global clinical process and clinical vendor audits across all clinical trials
  • Plan and conduct audits of specific clinical processes based on risk
  • Perform clinical vendor audits along with various SMEs (IRT, EDC etc.) to comprehensively assess all services provided by a vendor
  • Develop audit reports and distribute them to appropriate stakeholders
  • Own and manage related clinical vendor non-conformances
  • Review, understand, and audit clinical related regulations and guidelines (e.g. FDA regs, GCP, etc.)
  • Collaborate with clinical sourcing, supplier quality and clinical partnership to manage clinical vendors
  • Support the preparation, coordination, and participation of regulatory agency inspections
  • Participate in and support quality improvement projects
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About Paramus, NJ

Discover exciting job opportunities in the vibrant area around Paramus, New Jersey! Nestled in Bergen County, Paramus is a dynamic hub offering a perfect blend of urban convenience and suburban charm. Known for its proximity to the bustling Paramus Park Mall and the lush Saddle River County Park, this region boasts a thriving job market with endless possibilities for professional growth. With easy access to cultural attractions like the Bergen Performing Arts Center, a wide array of dining options ranging from classic diners to upscale restaurants, and just a short drive to catch a game at MetLife Stadium, Paramus is the perfect place to kickstart your career. Explore our job listings today and take your career to new heights in this exciting locale!
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