Overview Advarra Consulting seeks independent GxP auditors with experience in clinical research, quality assurance, and related life sciences to perform independent audits across GxP domains (GCP, GCLP, GLP, GMP, GVP, CSV).
Responsibilities Auditor Engagements (may include any of the following)
CRO Audits
GxP Training
Inspection Readiness Assessment and Training
Inspection Readiness Visits to Investigator Sites for Client-specific contracted projects
Mock Regulatory Inspections at Client facilities
Quality Tool Development (Storyboards)
GxP SOP Gap Analyses
GxP SOP Development
Requirements Education
Bachelor’s Degree or four (4) years equivalent experience
Experience
Minimum of ten (10) years clinical research and/or R & D experience in pharmaceutical, biotech, medical device and other life science industries.
Minimum of seven (7)

years working knowledge and experience in Quality Assurance
Knowledge/Skills/Abilities Strong GxP knowledge; (i.e., GCP, GCLP, GLP, GMP, GVP, CSV)
Proficient in the use of Microsoft Office
Familiarity with industry specific software and systems used in research and development
Collaboration with internal and external partners to include understanding client requirements and deliverables
Ability to communicate clearly and professionally in English (verbal, written, and presentation)
Seniority level Not Applicable
Employment type Contract
Job function Writing/Editing and Consulting
Industries: Business Consulting and Services
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Independent/Freelance GxP Auditor

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