Quality Engineer

7 days ago

ST Louis MO United States Indotronix Avani Group Full time

SUMMARY:

The Quality Engineer performs essential duties in ensuring the Stability Program operates effectively and in compliance with US and International pharmaceutical manufacturing regulations/guidance documents. The scope of responsibility includes packaging, storage and delivery of stability material in a timely manner to avoid undue burden on the testing laboratories, updating department Work Instructions or site Quality System Procedures and developing solutions to routine technical problems of limited scope to improve department efficiencies.


ESSENTIAL FUNCTIONS:

• Manages and maintains stability samples under ICH, FDA, DEA and cGMP regulations

• Pulls and delivers stability samples at testing intervals

• Package stability samples per study requirements

• Maintains controlled substance inventory in compliance with applicable DEA regulations

• Works with LIMS team to ensure stability module of LIMS system is maintained and functional

• Ensures stability studies are entered into LIMS accurately and timely

• Responsible for packaging, labeling, and storage of stability samples

• Shares responsibility for Stability Packaging functions and sample pulls as needed.


MINIMUM REQUIREMENTS:

Some technical, community college or college credits.

Minimum of 1-year related experience in Quality programs.

Some knowledge of pharmaceutical regulations including current GXP, GLP, or GMP requirements.

• Understanding and application of principles, concepts, practices, and standards within discipline.

• Knowledge of stability chambers and laboratory equipment.

• Ability to read and interpret graphs.

• Knowledge of ELN, LIMS, Excel, MiniTab.

• Understanding of basic statistical principles.


WORKING CONDITIONS:

50% Laboratory exposure to plant products, solvents and reagents, some of which are hazardous or potent compounds.

50% Office environment which includes sitting for long periods of time and computer use.

Works frequently with internal customers including QC, QA, Validation, and APIDs.

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