Tech Stack
Job Description, Responsibilities & Requirements
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 company that specializes in providing quality assurance and compliance services in the pharmaceutical industry. They are based in Northern New Jersey and are committed to ensuring GXP compliance with regulatory authorities.