• Bachelor’s Degree or Master Degree in Life Sciences, Pharmacy, Biology, Chemistry
• 4 years of related experience in a life science GxP environment with CRO experience preferred
• Hands-on experience with
• ICH-GCP (E6 R2/R3)
• FDA regulations (e.g., 21 CFR Part 11)
• EMA / EU CTR / Annex 11
• GxP frameworks (GCP, GMP, GLP, GCLP)
• Preferred certification
• ASQ Certified Quality Auditor (CQA)
• ISO 9001 / ISO 13485 Lead Auditor
• GxP Lead Auditor certifications (e.g., CQI/IRCA)
• Clinical QA certifications (e.g., CCQAP)
• High attention to detail
• Strong written and verbal communication
• Ability to meet deadlines and perform administrative functions
• Data review expertise across computerized systems including LIMS
• Understanding of Audit trails, metadata, and system validation
• Knowledge of Computer System Validation (CSV) and Computer System Assurance (CSA)
• Data governance frameworks
• Must be able to interpret raw data vs reported data discrepancies
• Microsoft Office suite proficiency including Office Word, Excel, PowerPoint
• Ability to organize tasks, work independently and adapt to changing priorities
• Ability to function independently within a minimally supervised environment with exceptional attention to detail required
• Demonstrated highly developed communication skills including well-developed writing skills and verbal and interpersonal skills
• Must be able to read, write, speak, fluently and comprehend the English language
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