The Planet Grouphttps://cdn.haleymarketing.com/templates/63515/logos/theplanetgroup-200x200.pnghttp://www.theplanetgroup.comhttp://www.theplanetgroup.comtrue
Posted: 01/26/20262026-01-262026-03-09Employment Type:ContractJob Category:ScientificJob Number: 642810Is 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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The Planet Group and our companies are equal opportunity employers. It is our practice not to discriminate against any employee or applicant based on any criteria, condition or basis protected by laws or regulations in the locations where we do business. All qualified applicants are encouraged to apply. We celebrate diversity and are committed to providing an environment of mutual respect. We believe that diversity, equity and inclusion enable us to better meet our mission and values while serving our clients across the globe. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter, or contact us, so that we can discuss the appropriate alternatives available.
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