GLP Auditor

Job Title: GLP Auditor Location: Ridgefield, CT Hours/Schedule: 40 hrs/wk Type: Contract Responsibilities Review procedures for compliance to GxP requirements and Company standards Conduct audits to support GLP studies (e.g.

protocol, amendment, study data, Principal Investigator reports such as Toxicokinetic reports, etc.) Issue electronic audit reports and perform follow-up actions Scan study records to facilitate audit requests Monitor and update electronic system with new audit requests Update the GLP Master Schedule as needed Conduct internal facility audits as needed Provide support during corporate audit and regulatory inspections as needed Requirements Requirements GLP Auditing or comparable experience Intermediate knowledge of relevant regulations and guidance Works independently with moderate guidance Excellent conflict resolution and negotiation skills Good organization skills Good to excellent verbal and written communication skills Desired Skills, Experience and Abilities Previous GLP Auditing Experience is preferred Previous Toxicokinetic/Bioanalytical experience is preferred Education: Bachelor s Degree or equivalent with 3 years of Pharma experience or equivalent Benefits System One offers eligible employees health and welfare benefits coverage options, including medical, dental, vision, spending accounts, life insurance, voluntary plans, and participation in a 401(k) plan.

Ref: #550-Joule Headquarters