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 (GCP, GMP, GLP, GVP, CSV)

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