QUALITY ASSURANCE ASSOCIATE Summary Enthusiastic Chemist eager pursue lasting career Agriculture industry. Detail-oriented Chemist expertise instrumentation, physical wet chemistry, formulation well coordinating testing development. Highlights HPLC GC FTIR UV-Vis Physical Chemistry techniques GMP/GCP Accomplishments Led pre-formulation formulation development topical cream gel psoriases successfully entered clinical trials. Experience 01/2011 Current Quality Assurance Associate Company Name － City State Preparation, configuration, execution authoring reports IQ, OQ PQ protocols Labware LIMS Trackwise Systems Managed quality systems change control, site training, deviation CAPA compliance programs Eisai. Other responsibilities include: Administration development Trackwise, Plateau Learning Management System Labware LIMS systems QA oversight validation activities Plateau Learning Management System Deviation investigations, CAPA SOP review site engineering automation systems Developed provided training local global change management, cGMP deviation/CAPA compliance processes site personnel Reviewed approved Master Batch Records (MBRs) Lot Packaging Records (LPRs) commercial batch release. Work within QA audit department regulatory site audits assist responding regulatory inspection observations. Support Clinical organization providing oversight clinical lot record packaging, specifically, review provide disposition decision packaged clinical trial material. 01/2005 01/2011 Senior Researcher Formulation Company Name － City State Lead formulation chemist design execution development programs deliver specific topical lyophilized product attributes. Designed studies substantiate formulation excipient choice, use levels desired product aesthetic attributes Responsible preclinical toxicology study drug product manufacture testing Generated interpreted study data determine physicochemical stability Drug excipient compatibility studies relevant studies, including solubility/pH-solubility profiles, pKA, partition coefficient studies formulation development process Communicated formulation development program status, goals timelines senior management by: Writing detailed technical reports completed formulation development programs periodic reports on-going programs Performed bi-monthly series technical presentations product development group regularly presented data monthly local project team meetings Scale-up process development cream formulation lyophilized parental formulations. Assisted preparation Chemistry, Manufacturing Control(CMC) sections IND, ANDA NDA submissions Evaluated clinical scientific literature identify potential product differentiators new product opportunities Employed chromatography, spectroscopy spectrophotometry techniques. 01/2003 01/2005 Quality Control Chemist Company Name － City State Responsible performing dissolution testing, content uniformity, acid resistance assay solid oral dosage products cGMP environment Managed stability program oral solid dose products Performed USP-NF Compendial testing ensure raw material compliance utilizing analytical wet chemistry techniques Investigated specification trend data appropriate CAPA. Authoring technical review analytical SOPs 01/2001 01/2003 Quality Control Analytical Chemist Company Name － City State Responsible performing physical chemical cGMP testing ophthalmic formulations Performed raw material, process finished product testing well method transfers Quality Control Developed validated stability indicating compendial non-compendial analytical methods accordance ICH FDA guidelines 01/1998 01/2001 Chemist Supervisor Company Name － City State Supervision busy contract laboratory Responsible running, developing validating methods wet chemistry ICP, AA GFLAA instruments Responsible preparation reports communication results customers 01/1995 01/1997 Chemist Company Name － City State Performed toxicological screening conformational studies using GC/MS horse serum urine illegal banned drugs metabolites Conducted qualitative quantitative analysis. Education 2014 Master Science Chemistry University North Carolina － City State US 1996 Bachelor Science Forensic Science Michigan State University － City State US Presentations Performed quarterly series technical presentations product development group regularly presented data monthly local project team meetings. Presented data formulation recommendations senior leadership Skills HPLC, GC, Physical Chemistry, UV/VIS