Sr. GCP Auditor (Office Based) - NCR
Novella Clinical Resourcing is seeking a Sr. GCP Auditor (Office Based in Durham, NC):
Performa variety of activities involved in assuring compliance with regulatoryrequirements by conducting audits, training programs, and reviewing andanalyzing data and documentation. Provide internal quality and regulatorycompliance consulting to other departments.
Developa quality assurance and regulatory compliance strategy for the XXXX. Independently plan and manages all audit related activities for internal auditsand sponsor audit facilitation, and third party vendors including CROs,technology vendors, and laboratories.
Conductinternal Project audit to ensure that studies are conducted in accordance withsponsor protocols, standard procedures, GCP, appropriate regulations andguidance
Plan,supervise, and perform audits. Conduct internal process audit to evaluatethe internal controls, communications, risk assessments and maintenance ofdocumentation as related to compliance with internal and external procedures,and quality and regulatory standards. Prepare and distribute auditreports.
Conductexternal audits of subcontractors for the purpose of vendor qualification,including due diligence review, vendor site audits, and periodicre-evaluations. Prepare and distribute audit reports.
Supportand/or conduct investigative site audit activities
Provideaudit observations to the auditee, review and assess Corrective and PreventiveAction (CAPA) provided by the auditee. Continue follow up with theauditee until all CAPA items are completed and closed.
Planand prepare for sponsor audits. Provide the audit agenda to the auditor/sand internal participants. Facilitate sponsor audits.
Providesponsor audit observations to the internal auditees, collect responses and CAPAfrom all involved in audit, send the responses to the sponsor on a timelymanner and by the due date.
Provideconsulting on SOP compliance, planned and unplanned deviation to otherdepartments
Provideconsulting on regulatory compliance to other departments
Participatein inspection readiness plans and activities
Draft,revise, and update Quality Assurance SOP’s and other QSD documents.
Reviewand approval of XXXX SOP’s. Provide consultation to all XXXX departmentswith the development of their SOP’s.
Developquality and risk assessment tools and checklists.
Facilitateproblem resolution and issue escalation
Performroot cause analysis to identify source of problems or non-conformances.
Analyzeand propose best practices for implementing and conducting audits andinvestigations.
Staycurrent with regulatory, quality, and industry trends related to GCP
Serveas a mentor to other QA/RC auditors and provide performance feedback to them.
Overseedepartment training and development including identification of training needs
Educateinternal and external partners on Quality Management System
EDUCATION,EXPERIENCE, AND SKILLS
Position requires a minimum of a BA/BS degree and aminimum of 6 years’ experience in pharmaceutical, medical, device, biotech, orclinical trial contract research industry, including minimum 2 years’experience in Quality Assurance and Regulatory Compliance/Affairs
- Strong analytical, problem solving skills
- Excellent written and verbal communication and interpersonal skills
- Detail oriented, good organizational traits
- Results oriented, multi-tasking, quick learner, respond to the urgent needs of the team and show a strong track record of meeting deadlines
- Good computer skills; inclination to adopt technology to maximize efficiency
- Self-motivated, with strong leadership abilities
- Good understanding of drug development and clinical trial process
- FDA Guidance on General Principles of Software Validation
- FDA Guidance on Computerized Systems Used in Clinical Investigations
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