Job Title: QC Chemist I, within the QC Technical Support function.
Roles and Responsibilities:
* Conducting analysis of cleaning validation samples, intermediates and finished product samples according to SOPs.
* Troubleshoots standard instrumentation/test methods.
* Perform routine calibrations on laboratory equipment
* Conducts procedure updates in QC lab and GMP reviews of logbooks.
* Coordinates waste management, LEAN and 5S efforts as required.
* Acts as a QC representative for a specialized area (like VMI support) in site meetings
* Supports Analytical Method Transfer testing where required.
* Reviews data and results of testing to ensure compliance to appropriate specifications
Skills & Expertise:
* Basic Knowledge of current Good Manufacturing Practices (GMPs) and Good Laboratory Practices (GLPs) on a daily basis.
* Knowledge of USP and other regulatory requirements.
* Knowledge of HPLC and UPLC systems.
* Proficiency in Microsoft Office applications.
* Ability to work effectively in a team environment.
* Strong verbal, written, and interpersonal communication skills are required.
* 0 years of relevant experience and a BS degree in Chemistry or equivalent.
* Prior lab experience would be a plus.
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