Category: AGRICULTURE

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