GCP Sr. Auditor

About the Position

Contract position

Hourly rate: $48.00

We are seeking a GCP Sr. Auditor to ensure 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. 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.

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.

Requirements

• 5+ years of pharmaceutical 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% Traveling required

We Offer

• Competitive hourly rate of $48.00
• Opportunity to work with a rapidly growing biopharmaceutical company
• On-site position in Paramus, NJ

About the Company

Talent One Services is a leading provider of talent solutions in the pharmaceutical industry, specializing in Neurology and Psychiatry therapies. We are committed to delivering high-quality services and supporting our clients in achieving their business objectives.