GCP Auditor jobs in United States
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Quality and Compliance Consulting, Inc. ยท 2 months ago

GCP Auditor

positionUnited States
timeFull-time
remoteRemote
senioritySenior Level
date5+ years exp

Quality and Compliance Consulting, Inc. (QC2) provides expert audit and consulting services to the pharmaceutical, medical device, and biotechnology industries. They are seeking full-time GCP auditors with experience in conducting on-site investigator site audits, both in the US and internationally, to join their team and support various GCP auditing activities.

Medical DevicePharmaceutical
Hiring Manager
Jason Bertram
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Responsibilities

Conduct US and international on-site investigator site audits
Conduct other on-site and remote GCP audits based on experience and expertise
Communicate with clients and auditees 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 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

GCP auditing experienceICH GCP guidelines knowledgeFDA regulations knowledgeAnalytical skillsCommunication skillsOrganizational skillsAttention to detailWork independently

Required

B.S./B.A. or higher degree
5-10 years industry experience
5-10 years GCP auditing experience
Excellent knowledge of ICH GCP guidelines and FDA regulations
Strong analytical and data review skills
Excellent written and verbal communication skills
Ability to work independently and remotely
Attention to detail and strong organizational skills
Ability to travel for three audits per month on average
Ability to travel internationally (many audits in 2026 will be international site audits)

Benefits

Medical and dental coverage
SIMPLE IRA company match
Paid vacation time
Work from home except when traveling for on-site audits

Company

Quality and Compliance Consulting, Inc.

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Quality and Compliance Consulting, Inc.
dateFounded in 1996
location
Henderson, Nevada, USA
people-size2-10 employees
web-link
http://qc2.com/

Funding

Current Stage
Early Stage
Company data provided by crunchbase