Google Cloud Platform Auditor Good Clinical Practices

Job Title: Google Cloud Platform AuditorJob Type: Full-time direct hireJob Location: Berwyn, PA (Hybrid)Salary: DoEWork Authorisation: Our preference is to hire someone local for a hybrid position

• Plan and conduct assigned audits
• Perform for cause audits as needed
• Write and issue audit reports, ensuring clear communication of audit findings to auditees and management
• Review responses to audit findings for appropriateness and completeness
• Close assigned audits
• Develop CAPAs as appropriate.
• Prepare for and host/support Regulatory Authority Inspections
• Write/review/revise QA SOP/WI
• Provide guidance to staff/management on quality related matters
• Contribute to creation of company QMS
• Appy critical thinking to identify solutions to non standard requests, issues and problems
• Require minimal instructions on day to day assignments
• May review vendor audit reports
• May provide coaching/training to company or vendor personnel

• Bachelor’s degree in life science, health-related or pharmaceutical field with advanced degrees in life science preferred but not required.
• CNS experience highly preferred
• At least 10 years relevant experience in Pharmaceutical, Biotech and/or CRO environment

• Previous experience in the conduct of multiple audit types (vendors, investigator sites, trial master files, data management and safety reporting) is essential
• In depth knowledge of Google Cloud Platform requirements
• Knowledge of medical and technical terminology related to the audit type being conducted
• Computer literacy commensurate with job requirements (e.g. Microsoft Office Suite)
• Able to handle multiple tasks to meet timelines in dynamic environment
• Ability to negotiate and provide constructive feedback
• Excellent communication skills and the ability to write concise, accurate reports and other necessary documentation
• Fluency in English, both written and verbal.