gregory zenyuh

* Utilized a variety of procedures, instrumentation, equipment, and software to test the potency, as well as the purity, of the pharmaceuticals that Mylan produces * Served as mentor for new analysts on the weekend day shift * Performed analyses on raw materials, intermediates, blends, and finished products, including troubleshooting of instrumentation * Reviewed and approved documentation and paperwork from other Chemists, as well as Dissolution analysts * Technical audit trained to review documentation and paperwork * Reviewed, processed, and interpreted data and results to ensure specifications were met, maintained instrument logbooks, completed laboratory worksheets and relevant documentation according to FDA and cGMP documentation practices, and reviewed and compiled information into the report format

* Quality reviewed and closed laboratory investigation reports (LIRs) from all quality control laboratories, including high performance liquid chromatography (HPLC), dissolution, wet chemistry, gas chromatography, and microbiology * Quality reviewed and closed quality impact assessments (QIAs) from multiple departments, including quality control, quality assurance, and quality compliance * Initiated manufacturing investigation reports (MIRs), pre-market supply incident forms (PMSIs), trending assessments, and corrective and preventive actions (CAPAs), as required in support of LIRs and QIAs * Trained to author and approve controlled documents within the Documentum systenm * Trained to author standard operating procedures (SOPs( within the Documentum system * Routinely updated controlled lists within the Documentum system in support of CAPA closure