Quality Control Chemist II

TriRx Shawnee LLC•Huntsville, AL

2d•Onsite

About The Position

A Chemist II evaluates the chemical and physical properties of various raw materials and finished products under cGMP guidelines. Utilizes established methods and procedures and laboratory equipment to perform the analytical testing and ensure all products released are safe and efficacious. Performs method transfer and validations, and conducts laboratory investigations.

Requirements

Bachelor’s degree in Chemistry or Related Field
Minimum of 1 year experience in an analytical laboratory
Knowledge of FDA regulations
Familiarity with Good Manufacturing Practices (GMPs)
Familiarity with analytical laboratory operations and associated safety requirements
Possesses an expanded understanding of column chemistry with ability to troubleshoot most problems without support.
Experience with chromatographic equipment and integration software
Experience with Microsoft Office Suite of Products, including Word, Excel, and Teams
Analytical laboratory experience
Must be capable of wearing all appropriate PPEs correctly during handling of hazardous substances
Some work may require extended periods of time standing at a lab bench
Must be visually capable of accurately measuring and reading volumes of solution in volumetric apparatus (i.e. accurately read meniscus)

Responsibilities

Maintain a clean, organized, and safe work area.
Perform daily calibrations and maintenance on analytical equipment, such as analytical balances, pH meters, density meters, etc.
Prepare test solutions, compounds, or reagents for analysis of raw materials and finished products.
Accurately and precisely perform analytical testing using a variety of wet chemistry techniques, such as weighing and measuring, density, specific gravity, pH, viscosity, titration, and conductivity.
Perform assay, impurity/degradant, and solvent determinations by chromatographic analysis via thin-layer, gas (GC), high performance (HPLC), Mass Spectroscopy, and ultra performance chromatography (UPLC).
Perform minor maintenance and troubleshooting on chromatographic equipment.
Multitask projects while maintaining high levels of accuracy.
Complete basic laboratory investigations with a thorough understanding of root cause analysis and required CAPAs.
Work in cross functional teams as necessary to complete projects, transfers, and investigations.
Maintain current training compliance on assigned SOPs and company policies.
Accurately and legibly document and record all work completed so that analyses may be fully traceable and reproducible.
Identify as an expert on at least one type of laboratory equipment, and acts as a SME for that instrument.
Operate under all corporate safety requirements at all times, including use of PPEs and adherence to company policies in handling of hazardous substances.