Chemist II; Quality Control

Position Summary:

The Chemist II is responsible for and has a moderate level of experience in performing chemical analysis for one of the assigned QC laboratories (Raw Material, Finished Product, Technical Support) which is responsible for the analysis and disposition of commercial materials (raw materials, finished product release, stability, validation, investigation), and environmental samples, as assigned, and documenting results in accordance with SOPs.

Responsibilities: Responsibilities include, but are not limited to:

• Follow all laboratory SOPs, including but not limited to laboratory safety, chemical handling and storage, gowning, equipment use, cGMP, GDP, data integrity, DEA requirements, etc.
• Perform laboratory chemical analysis on raw materials, in-process materials, and/or finished product, using ICP-OES/MS, UV-Vis, Fluorescence, GC, HPLC/UPLC, titration, and other wet chemistry techniques, as assigned, in accordance with the prescribed approved analytical test method.
• Execute assay testing, content uniformity testing, impurities analysis, method transfers, cleaning validation testing, and process/interpret data at a moderate level with minimal to no errors.
• Maintain a clean and organized laboratory working environment.
• Dispose of used/expired/excess chemicals, solutions, solvents, etc. in dedicated waste receptacles.
• Report well-written, accurate and timely results.
• Review data, calculations, notebooks, and reports.
• Assist in laboratory investigations, as assigned.
• Assist in Process validation testing and protocol/report review, as assigned.
• Maintain and troubleshoot laboratory equipment at a moderate level.
• Suggest improvements to existing testing methods when possible.
• Assist with routine Metrology functions, including instrument cleaning/ preventive maintenance/ calibration/ verification activities.
• Monitor and assist with maintaining proper inventory levels of all laboratory supplies.
• Assist with sample receiving, chemical inventory, document filing, housekeeping, etc.
• Responsible for compliance with all rules and regulations pertaining to safety policies with the proper attitude toward safety and health, helping to ensure that all department operations are performed with the utmost regard for the safety and health for all personnel.
• Other responsibilities as assigned by Management.