Joseph Jasinski Email & Phone Number

Oak Brook, Il

Chicago

Analyzed raw materials, finished product, stability and in-process samples via HPLC, Capillary Electrophoresis, UV/VIS, and pH to support manufacturing, and Analytical Research and Development studies, and stability testingTroubleshot method and equipment issuesSupported Regulatory filings and responsesSuccessfully completed FDA PAI inspection: directly interacted with inspectorsControlled inventory for Capillary Electrophoresis testing materials (consumables) and necessary wear-and-tear adjunct equipmentWrote deviations, investigations, CAPAs, pro-forma worksheets, updated Standard Operating Procedures (SOP) and Test MethodsTrained analysts on Test MethodsValidated Capillary Electrophoresis and HPLC test methods

Melrose Park, Il 60160

Analyzed raw materials, finished product, stability and in-process samples via HPLC, GC, Capillary Electrophoresis, Karl Fischer, Particle Size, Particulate Matter, UV/VIS, and pH to support formulation development studies and stability testingTroubleshot method and equipment issues during formulation supportScheduled weekly wet chemical and analytical equipment testing for Analytical Research & Development groupCoordinated stability testing and record management for all Product Development (PD) utilizing Micro Control Solutions (MCS), and reported all stability metrics for APQR and management reviewControlled inventory for Capillary Electrophoresis testing materials (consumables) and necessary wear-and-tear adjunct equipmentAudited stability program for PD/Stability Department against ICH and SOPs as part of Internal AuditDeveloped and performed customized analytical testing in response to Customer Complaints Wrote deviations, validation protocols, validation reports, pro-forma worksheets, final test reports, Standard Operating Procedures (SOP) for instrument operations, and Out-Of-Specification (OOS) reportsMember of Departmental Teambuilding Committee for organization, preparation, and execution of activities to promote employee collaboration and relationship buildingTrained the Analytical group to maintain cGMP training complianceValidated HPLC test methods for finished product

Melrose Park, Il 60160

Analyzed raw materials, finished product, stability samples and in-process samples via HPLC, GC, Karl Fischer, Particle Size, FTIR, Particulate Matter, and pHSupported formulation of antineoplastic-protein bound products for accelerated launch to US, EU, Japan, and AustraliaValidated HPLC test methods for FP, IP and cleaning qualification for manufacturingWrote deviations, validation protocols, validation reports, pro-forma worksheets, final test reports, SOPs for instrument operations and OOS reportsDeveloped HPLC test methodsBecame a Qualified Trainer in October 2008Participated in regular meetings to improve the safety of the laboratory work environmentSupported formulation during trial-proprietary batch production as well as clinical batch production in Grand Island, NY

Melrose Park, Il 60160

Analyzed raw materials, finished product, stability samples via HPLC, Karl Fischer, FTIR, DSC, TGA, and pHPerformed method transfer to Quality Control groupDrafted and issued Certificates of Analysis for exhibit batchesPerformed validation of test methods