Senior Specialist, Quality Control Chemist II (2nd shift)
Core
Ensures compliance with regulatory standards by inspecting and analyzing pharmaceutical materials, components, and products for quality and safety.
Role type
Senior Specialist, Quality Control Chemist
Builds
Pharmaceutical products and drug substances
Domain
Pharmaceutical manufacturing / Regulatory compliance
Required skills
Analytical chemistry, Method validation, Stability testing, SOP authoring, Deviation investigation, CAPA execution, Visual assessment, Regulatory knowledge (21 CFR 210/211), Laboratory investigations
Preferred skills
Chemistry or biology degree, 2+ years in FDA regulated industry, GDP documentation, Technical writing, Microsoft Excel/Word proficiency
Technologies
Analytical instruments, Laboratory Information Management Systems (LIMS), Computer systems
Responsibilities
Inspect and analyze incoming materials, drug substance, in-process, and drug product samples; Execute method verification, validation, and transfer protocols; Perform stability testing; Author SOPs, forms, and documentation; Conduct investigations, deviations, change controls, and CAPAs; Perform visual and analytical evaluations.
Seniority
Senior Specialist, hands-on IC
