Principal Specialist, Quality Control Chemistry Testing (Weekend Shift)
Core
Technical leader responsible for analyzing and inspecting pharmaceutical/medical device products and processes for compliance with specifications, standards, and cGMP regulations.
Role type
Senior IC quality control chemistry specialist
Builds
Radiopharmaceutical products and processes
Domain
Healthcare / Pharmaceutical manufacturing / Chemistry
Required skills
Analytical chemistry, cGMP compliance (21 CFR 210/211), SOP authoring, method validation, stability testing, laboratory investigations, instrumentation qualification, technical writing
Preferred skills
Subject matter expertise, cross-functional collaboration, process improvement, regulatory knowledge
Technologies
Analytical instrumentation, Microsoft Word, Microsoft Excel
Responsibilities
Perform analysis of incoming materials, in-process, and product samples; Execute method verification, validation, and transfer protocols; Lead qualification of analytical instrumentation; Perform stability testing and laboratory investigations; Author and optimize SOPs and documentation; Provide technical mentorship and training to personnel.
Seniority
Senior, hands-on IC
