GCP Auditor

Katalyst Healthcares & Life Sciences

Paramus, NJ

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JOB DETAILS

SKILLS

Auditing, Biotech and Pharmaceutical, Calendar Management, Clinical Practices/Protocols, Clinical Trial, Electronic Data Capture (EDC), FDA Requirements, GCP (Good Clinical Practices), Healthcare, Healthcare Quality, Information Technology/Systems Audit, Policy Development, Procedure Development, Quality Management, Regulations, Reporting Skills, Risk, Standard Operating Procedures (SOP), Team Player, Vendor/Supplier Evaluation, Vendor/Supplier Management, Vendor/Supplier Sourcing, Willing to Travel

LOCATION

Paramus, NJ

POSTED

30+ days ago

Roles & 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 allservices 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.

Education & Experience:

2+ 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

About the Company

Katalyst Healthcares & Life Sciences

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