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Position Overview
The Quality & Validation Chemist Specialist supports validation, quality, and laboratory activities within a regulated medical device or pharmaceutical manufacturing environment. This role ensures processes, equipment, analytical methods, and quality systems remain compliant with GMP, ISO, and regulatory requirements while providing technical expertise in chemistry and analytical testing.
Primary Responsibilities
Execute and document process, cleaning, analytical method, and equipment validation activities.
Support equipment and system qualification (IQ/OQ/PQ).
Prepare and review validation protocols, reports, risk assessments, and supporting documentation.
Investigate deviations, non-conformances, and out-of-specification (OOS) results.
Perform root cause analysis and support CAPA development and effectiveness reviews.
Review batch records, validation dat...