Quality Control Chemist will perform analyses, inspection, and testing of products, raw materials, in-process materials, and stability samples for a growing pharmaceutical manufacturer.
- Performs qualitative and quantitative assays on samples, to ensure quality standards and compliance with company standards, customer and governmental regulatory requirements (FDA, USP), and product specifications for the chemical or physical properties.
- Analyze samples using appropriate instrumentation (depending on training, some or all of the following would apply – HPLC, GC, UV, IR, KF, pH, etc.) while following current Methods & Procedures (SOPs).
- Process and report HPLC instrumental analysis using data processing software
- Process and report other instrumental analysis using the instrument specific data processing software.
- May be involved or responsible for performing Laboratory Investigations, Change Controls, audit/review of laboratory data, implementing CAPA, Planning and scheduling laboratory activities, and coordinating process improvements. nd analytical p
- BS/BA in Chemistry, or related Life Science
- Minimum 1-3 years in a pharmaceutical laboratory environment, ideally performing HPLC and GC analytical instrumentation in a Quality Control (QC) setting.
- Pharmaceutical & FDA/GLP industry experience is preferred over academic laboratory experience.
- Demonstrated understanding of cGMPs, cGLPs, FDA regulations, and industry guidelines, as well as international regulatory guidelines. Knowledge of compendia procedures desired.
- Ability to keep neat, accurate and complete records and logs.
- Must be proactive, results oriented, with a strong attention to detail
- Proficiency with chromatography software, Microsoft Office products including Word and Excel.