Advarra ยท 8 hours ago
Ex-FDA Inspector for Mock Inspections GxP
United States
Contract
Remote
Entry, Mid Level
2+ years exp
Maximize your interview chancesPharmaceutical
Hiring Manager
Benjamin Sager
Insider Connection @Advarra
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Responsibilities
Inspection Readiness Assessment and Training
Inspection Readiness Visits to Investigator Sites for Client-specific contracted projects
Mock Regulatory Inspections at Client facilities
Inspection Support at Client facilities
Global Engagements (as applicable and agreed)
Investigator Site Audits
CRO Audits
Vendor Audits
GxP Training
GxP SOP Gap Analyses
GxP SOP Development
Qualification
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Required
Minimum of two (2) years working for the FDA as an Inspector for one or more GxP fields
Minimum of four (4) years working knowledge and experience in Quality Assurance
Strong GxP knowledge; (i.e., GCP, GcLP, GLP, GMP, GVP)
Excellent writing and communication skills.
Computer skills in WORD, EXCEL and Power Point;
Familiarity with industry specific software and systems used in research and development
Ability to work independently
English: Spoken, Written and Read - Excellent
Company
Advarra
Advarra leverages exceptional client service, innovative technology, enhanced regulatory expertise and global research compliance services.
501-1000 employees
Funding
Current Stage
Late StageTotal Funding
unknown2022-06-10Acquired
Leadership Team
Gadi Saarony
Chief Executive Officer
Christian Rockwell
Senior Vice President of Marketing
Recent News
Digital Music News
2024-12-16
2024-05-20
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