QA Specialist, I
Core
Ensure product quality and compliance with internal procedures and external standards through batch record review, deviation management, and quality system oversight.
Role type
QA Specialist (GxP)
Builds
Clinical and commercial pharmaceutical products
Domain
Biopharma / Pharmaceutical Manufacturing
Required skills
Root Cause Analysis (RCA), technical writing, FDA regulations knowledge (21CFR Parts 210, 211, 820), Risk Management Tools (FMEA, HACCP, PHA), GxP compliance, batch record review, CAPA management, change control, deviation investigation
Preferred skills
ASQ certification, late-stage clinical/commercial production experience
Technologies
MS Office (Word, Excel, Access, Visio)
Responsibilities
Review and approve batch documentation and master batch records; manage deviation, investigation, and CAPA programs; review and approve quality system procedures and change controls; perform risk assessments; ensure site readiness for regulatory inspections; provide training on department procedures.
Seniority
Mid-level, hands-on IC
