Quality Specialist I
Core
Ensure quality compliance across pharmaceutical manufacturing operations through documentation review, process monitoring, and regulatory investigations.
Role type
Quality Specialist I (Manufacturing)
Builds
Bulk drug substance manufacturing, testing, and distribution
Domain
Pharmaceutical manufacturing / GMP compliance
Required skills
GMP regulations knowledge, batch record review, quality investigations, root cause analysis, CAPA management, SOP writing, quality systems software proficiency, environmental monitoring principles
Preferred skills
BS in Chemistry/Biology/Engineering, ISO auditor certification, Six Sigma certification
Technologies
TrackWise, Documentum, EDMS
Responsibilities
Review batch records and perform quality investigations, monitor business process performance measures, support training program development, participate in audits and inspections, administer quality system tools, assist in writing and revising site SOPs
Seniority
Mid-level, individual contributor
