| | | 20,000+ Fresh Resumes Monthly | |
|
|
| |
Click here or scroll down to respond to this candidateCandidate's Name
Home AddressStreet Address Buckwalter Rd Royersford, PAPHONE NUMBER AVAILABLEEmail: EMAIL AVAILABLEObjectiveTo obtain a position that will enable me to use strong organizational skills, educational background, and ability to work and lead well in a team atmosphereEducationTemple University, Philadelphia, PA 08/2003-08/2008Major: ChemistryDegree: B.A. ChemistryWork ExperienceMerck & Co, West Point, PAPosition: Senior Specialist, Quality 09/2020-PresentCollaborates Globally on meetings as a Site Process Steward for GCM TrackwiseBusiness CoP lead of our area in IPI ImplementationMaintains the WPQO Change Control Unit MailboxReviews submissions for Quality and initiates SQL *LIMS and GLIMS Change control requests (Vaccine, Pharm, Stability, EM)Reviews submissions for Quality and initiates LIMS Change Control requestsVerification in GCM Trackwise, and second signature on LIMS applicationsImplements GLIMS change controls, also maintains 3LIMs, when on callCollaborates across sites interacting all IPTs at West Point, Durham, and Globally for GLIMSLead Change Analyst on the GLIMS for implementation in Global Vaccines and Biologics (Stability GLIMS project, Phase 1 and Phase 2)Lead Change Assessment Tier for GLIMS changesReviews and author Standard Operating proceduresMerck & Co, West Point, PAPosition: Specialist, Quality Assurance 02/2018-09/2020Maintains the WPQO Change Control Unit MailboxReviews submissions for Quality and initiates SQL *LIMS and GLIMS Change control requests (Vaccine, Pharm, Stability, EM)Reviews submissions for Quality and initiates GLIMS Change Control requestsAssisted LIMS team on special WIN 10 project -Performed test runs on Excel Workbooks, EM personnel verification in GCM Trackwise, and second signature on LIMS applicationsCollaborates across the West Point site interacting with multiple Change Review Boards for process changes including PnP Expansion, Barrier, Sterile Supply, SPS, D&L, SiteLead Change Analyst on the GLIMS project for implementation at the West Point SitePre and Post approve ECOs for the supporting areas across sitePast member that leads the Analytical Change Request Change Review Board and maintains the WP CRA Advisory Council mailboxMerck & Co -via On Board, USA, West Point, PAPosition: Stability Analyst-LIMS 07/2017-02/2018Created, maintained, and executed Environmental Monitoring LIMS (Pre-Approval) and Product Change Controls in TrackwiseExecute updates in SQL *LIMS as per Change control requestsCreated and edited user Accounts in SQL*LIMS (Maintain all incoming user applications for SQL*LIMS)Performed test runs on Excel WorkbooksTeva Pharmaceuticals, Horsham, PAPosition: Quality Analyst 04/2015-07/2017Created, maintained, reviewed, and approved document Specifications in Laboratory Information Management System (LIMS)Edited, Reviewed, and made documents effective in Wisdom (Document Management System)Ensure compliance of quality control documents by authoring change controls (Trackwise) while managing the lifecycle through the systemDetermine testing requirements and write protocols accordingly for method transfer, method validation and USP verification testingTeva Pharmaceuticals, Sellersville, PA 09/2011-04/2015Position: Associate Scientist IIPerformed all required testing to release batches of pharmaceutical drugs in a Quality Control atmosphereWorked with the Metrology group in calibrating HPLC instrumentsCompleted and managed many small projects consisting of method transfers, method validations, and standard qualificationsAssisted and Executed writing/reviewing protocols, reports, and data packetsLead chemist on Secondary Standard Qualification projectMaintained and authored protocols and reports for Secondary Standard Qualification projectAssisted on inventory of controlled substances that came in and out of the laboratory, while working in compliance with the DEA representativesMerck & Co, West Point, PA 09/2010-09/2011Position: BiotechnicianResponsible for executing the functions required to produce the varicella vaccine on virus side in an aseptic environmentPerforms work duties using automated systems (Delta V, BOI, LIMS) or manual operations in compliance with safe operating procedures, company and government regulations, and good manufacturing practices.Cleans, assembles, operates, disassembles, maintains, trouble shoots and initiates corrective actions as necessary to meet production schedulesURL Pharma, Philadelphia, PA 09/2008-09/2010Position: Quality Control Chemist/AnalyticalPerform all testing for the release of lots/batches of pharmaceutical drugs in theQuality Control-Finished Product and Stability departmentsAnalyze, record, and maintain reproducible data, qualitative and quantitative,according to cGMP guidelines, SOPs, and FDA regulationsSkills/ActivitiesInstruments: IR, UV, GC/MS, HPLC, NMRTraining in: UV-Vis, KF, Dissolution, GCTLC, HPLC-Waters/Empower, Impurities/Degradations, Blend UniformitySQL* LIMS, Laboratory LIMS (GLIMS), Wisdom/Midas, MEDS, eVal (Kneat), Trackwise, IPIPower Application, Microsoft TeamsWindows XP; Excel, Word, and PowerPointLabware 8 Administration 1 ; Labware 8 Basic Configuration |
