Principal Specialist, Quality Control Chemistry Testing (2nd Shift)
Core
Technical leader responsible for analyzing and inspecting pharmaceutical/medical device products and processes for compliance with cGMP and regulatory standards.
Role type
Senior IC quality control chemistry specialist
Builds
Radiopharmaceutical products and medical devices
Domain
Healthcare / Pharmaceutical manufacturing / Chemistry
Required skills
Analytical chemistry, cGMP compliance, SOP authoring, method validation, laboratory investigations, instrumentation qualification, technical writing, regulatory knowledge (21 CFR 210/211)
Preferred skills
Subject matter expertise, cross-functional collaboration, process improvement, training others
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; perform stability testing; lead laboratory investigations and corrective/preventative actions; author and optimize SOPs and documentation; mentor personnel in the chemistry department.
Seniority
Senior, hands-on IC
