Quality and Compliance Consulting, Inc. ยท 20 hours ago
GCP Auditor
United States
Full-time
Remote
Senior Level
5+ years exp
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Hiring Manager
Jason Bertram
Insider Connection @Quality and Compliance Consulting, Inc.
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Responsibilities
Conduct US and international on-site and remote audits
Communicate with clients and auditees as needed and review documents to prepare for audits
Prepare audit agendas
Prepare audit reports and make revisions based on internal QC2 and client feedback
Review audit responses and corrective actions
Pre-audit and post-audit calls with clients, when requested
Peer-review QC2 audit reports
Consult with clients on quality management and GCP related issues
Based on skillset, support client written procedure development or provide other specialized guidance on operations and quality
Periodic review of internal QC2 SOPs
Qualification
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Required
B.S./B.A. or higher degree
5-10 years industry and/or auditing experience in one or more of the areas listed in the above Job Overview section
Excellent knowledge of ICH GCP guidelines, FDA regulations, and applicable local regulations
Strong writing skills
Strong communication and interpersonal skills
Self-driven, with ability to work independently and meet deadlines
Ability to travel for two to three audits per month (up to 9-12 nights a month)
Ability to travel internationally
Benefits
Medical and dental coverage
SIMPLE IRA company match
Paid vacation time
Work from home except when traveling for on-site and hybrid audits
Company
Quality and Compliance Consulting, Inc.
Quality and Compliance Consulting, Inc.
2-10 employees
Funding
Current Stage
Early StageCompany data provided by crunchbase
