Quality Assurance Specialist III

The QA Specialist provides independent Quality support for GLP and GCLP studies by performing document review, protocol and experiment record review, data review, and quality event oversight activities.

Requirements

• 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)