Quality Specialist I
Core
Quality Specialist supporting clinical trial projects by ensuring compliance with regulatory requirements, GMP, and SOPs through documentation, inspection, and release activities.
Role type
Quality Specialist I (GMP Manufacturing)
Builds
Clinical trial supplies and drug delivery products
Domain
Life Sciences / Pharmaceutical Manufacturing
Required skills
GMP compliance, documentation management, inspection, data review, CAPA management, change control, deviation investigation, metric tracking
Preferred skills
Bachelor's degree in scientific discipline, scientific reasoning, computer proficiency
Technologies
GMP systems, batch record software, computer technology
Responsibilities
Inspect components and materials, create Certificates of Analysis, review quality control data and approve release packets, file and redact batch records, support floor QA activities (audits, cleaning, line clearance), perform label inspections, lead investigations for deviations and complaints, track and trend metrics, host change control review board meetings
Seniority
Entry-level (High School degree + 2 years experience)
