• Conducts analytical method transfers, verifications, and validations to expand QC laboratory capabilities• Provides chemistry based expertise in business decisions and strategies for FDA responses• Adheres to strict quality guidelines (ICH, GMP, USP/EP, ISO)• Authors and reviews protocols, SOPs, reports, and specifications • Coordinates raw materials, excipients, and finish product testing with external contract laboratories • Performs routine chemistry and microbiology… Show more • Conducts analytical method transfers, verifications, and validations to expand QC laboratory capabilities• Provides chemistry based expertise in business decisions and strategies for FDA responses• Adheres to strict quality guidelines (ICH, GMP, USP/EP, ISO)• Authors and reviews protocols, SOPs, reports, and specifications • Coordinates raw materials, excipients, and finish product testing with external contract laboratories • Performs routine chemistry and microbiology analysis and associated data review Show less

• Develops and validates analytical test methods for drug-device combination products• Designs and executes protocol driven experiments to aid method development• Authors, revises, and implements SOPs for new instrumentation and analytical methods• Modernizes legacy HPLC test methods via HPLC to UPLC method transfers• Conducts exploratory research to foster innovation that potentially leads to new products• Coordinates and communicates with other business units & departments… Show more • Develops and validates analytical test methods for drug-device combination products• Designs and executes protocol driven experiments to aid method development• Authors, revises, and implements SOPs for new instrumentation and analytical methods• Modernizes legacy HPLC test methods via HPLC to UPLC method transfers• Conducts exploratory research to foster innovation that potentially leads to new products• Coordinates and communicates with other business units & departments regarding project details and timelines Show less

• Performed high throughput pharmaceutical analytical testing on various medical devices to support manufacturing facility• Performed various analytical techniques (dissolution, assay/degradation products, content uniformity, etc.)• Adhered to strict quality guidelines (ICH, GMP, USP/EP, ISO)• Devised and implemented process improvements to increase overall throughput and efficiencies of the laboratory• Performed data review to ensure complete and error-free data prior to… Show more • Performed high throughput pharmaceutical analytical testing on various medical devices to support manufacturing facility• Performed various analytical techniques (dissolution, assay/degradation products, content uniformity, etc.)• Adhered to strict quality guidelines (ICH, GMP, USP/EP, ISO)• Devised and implemented process improvements to increase overall throughput and efficiencies of the laboratory• Performed data review to ensure complete and error-free data prior to release of CofA• Handled flammable, corrosive, carcinogenic, and other potentially harmful chemicals Show less

• Reviewed and validated data provided by an environmental analytical testing laboratory• Wrote detailed data validation reports that outlined findings in the testing data• Provided support to field team for chemistry related inquiries• Conducted facility environmental sampling of soil, surface water, and groundwater in accordance with strict regulatory procedures• Provided oversight of monitoring well drilling operations• Maintained a logbook with detailed notes during… Show more • Reviewed and validated data provided by an environmental analytical testing laboratory• Wrote detailed data validation reports that outlined findings in the testing data• Provided support to field team for chemistry related inquiries• Conducted facility environmental sampling of soil, surface water, and groundwater in accordance with strict regulatory procedures• Provided oversight of monitoring well drilling operations• Maintained a logbook with detailed notes during field sampling Show less

• Performed numerous routine analytical techniques on water and soil environmental samples• Operated, calibrated, and maintained laboratory instruments: ion chromatograph, KONELAB chemical analyzer, UV-spectrophotometer, alpkem autoanalyzer, analytical balances• Prepared standards/reagents for sample analyses• Utilized LIMS system• Performed data review to ensure complete and error-free data is sent to clients• Handled flammable, corrosive, carcinogenic, and other… Show more • Performed numerous routine analytical techniques on water and soil environmental samples• Operated, calibrated, and maintained laboratory instruments: ion chromatograph, KONELAB chemical analyzer, UV-spectrophotometer, alpkem autoanalyzer, analytical balances• Prepared standards/reagents for sample analyses• Utilized LIMS system• Performed data review to ensure complete and error-free data is sent to clients• Handled flammable, corrosive, carcinogenic, and other potentially harmful chemicals• Inventoried, ordered, and stocked lab supplies Show less

• Performed a textural analysis test on sediment samples • Handled various chemicals

• Managed 8-12 employees daily• Trained and onboarded new employees on daily work expectations and safety protocols• Promoted and monitored safety regulations of employees• Created employee schedules and tracked timecards• Monitored errors in packaging and sorting prior to shipment so packages to ensure customer service• Updated and implemented new safety regulations, company goals, and overall performance expectations from monthly supervisor meetings• Coordinated and… Show more • Managed 8-12 employees daily• Trained and onboarded new employees on daily work expectations and safety protocols• Promoted and monitored safety regulations of employees• Created employee schedules and tracked timecards• Monitored errors in packaging and sorting prior to shipment so packages to ensure customer service• Updated and implemented new safety regulations, company goals, and overall performance expectations from monthly supervisor meetings• Coordinated and ensured the timely departure of trailers Show less

• Loaded packages from a conveyor belt into a trailer at a mandatory PPM (packages per minute)• Member of the safety committee and promoted the safety rules while working• Mentored new employees on how to load trailers correctly and work safely