Quality Assurance Auditor
Possess thorough in-depth knowledge and clear understanding of Good Clinical Practices (GCP), International Conference on Harmonization (ICH) guidelines, Federal Drug Administration (FDA) guidelines, Current Good Manufacturing Practices (cGMP) and HIPPA rules and regulations.
- Conduct internal compliance audits on multiple Phase I clinical trial studies for their compliance with state/ federal regulations, investigational plan (IRB approved protocol) and company standards.
- Oversee the reported trial data is accurate, complete and verifiable from source documents.
- Perform monthly in-process audits observing technical and professional staff on procedures making sure they are adhering to protocol specifications and internal standard operating procedures (SOPs).
- Perform quarterly employee training record audits on current staff to assure appropriate education and training of staff's particular roles in the trial are met.
- Assure implementation of any resulting corrective action plan (CAPA).
- Utilize audit outcomes to identify quality related trends and areas of risk appropriately escalating any issues to relevant management personnel.
- Ensure the documentation of storage, handling, dispensing and return of investigational product (IP) are completed per protocol and company SOPs.
- Audit regulatory and essential documents for completion and accuracy
- Ensure effective closure of audits by working with 'auditees' to ensure comprehension, development and execution of corrective/preventative actions with regard to any non-conformities cited during audits.