Analytical Chemist I

SUMMARY:

Analytical Chemist I perform routine and non-routine analytical quality control analysis of raw materials, in-process, finished products and stability samples with compliance to GMPs and corporate standards and adhering to regulatory requirements.

RESPONSIBILITIES:

• Accurately performs testing per compendia or vendor methodology on raw materials and in-process, finished product, and stability testing per specifications and within procedural and regulatory requirements.
• Work with laboratory instruments including but not limited to HPLC, GC, FTIR, UV-Vis, pH meter, and Karl Fischer.
• Read, understand, and follow standard operating procedures (SOPs) raw material specifications, validation instructions, test sheets, and company policies and processes.
• Write or review SOPs, methods, laboratory investigations, equipment, and software IQOQs.
• Document laboratory work in accordance with cGMP and regulatory standards and a high level of integrity and accuracy.
• Perform data review on daily calibration checks, equipment maintenance, and solution preparations.
• Train new Analytical Chemist I on methods and instrumentation.
• All other tasks as requested or assigned.

QUALIFICATIONS AND REQUIREMENTS:

• Bachelor's degree in chemistry or related field.
• Experience and knowledge of HPLC, GC, AAS and Wet Chemistry procedures, etc. required.
• Knowledge of Laboratory systems for Reference Standards, Chemical Inventory, Calibrations, Volumetric Solution Preparation and Expiration, Notebook documentation standard, calculations and reporting standards required.
• 1+ years' experience in pharmaceutical and/or cGMP laboratory preferred.
• Proficiency in Microsoft Office Suite (Word, Excel, and Outlook) required.
• Detailed-oriented with high level of accuracy and integrity in laboratory testing and documentation.