Montgomery Street, San Francisco, CA94105609 Johnson Ave., 49204, Tulsa, OK Home: (555) 432-1000 - Cell: - resumesample@example.com - -
Professional Overview
Quality Control Scientist with 17 years in Quality Control experience including supervising and managing ALCM remediation teams comprised of scientists and analysts working to remediate analytical methods. Excel in organizing, writing, reviewing, and editing Qualification and Validation plans, protocols, and reports. Proficient in Microsoft programs. Expert in analytical instrumentation Microbiological techniques with extensive Qualification and Western blotting Validation experience Automated equipment Expert in data analysis Leader in data presentation Experimental design
Summary of Skills
Guest services
Inventory control procedures
Merchandising expertise
Loss prevention
Cash register operations
Product promotions
Education
Expected in
MBA: University of Maryland University College - Adelphi, Maryland GPA: Master of Business Administration
Expected in
Bachelor of Science: Salem State University - Salem, Massachusetts GPA: BSc. Biology
Professional Experience
01/2012 to Current
Scientist I - Study DirectorBatteries Plus, Llc – Decatur, AL,
Analytical Lifecycle Management (ALCM) Study Director for ELISA remediation projects Design, author, review, and approve qualification and validation protocols and reports, SOPs, transfer reports, and IOPQ reports in accordance to cGMP guidelines and ACH requirements Assay validation/co-validation Document, review, and approve Change Control requests and deviations Technical method transfer to Quality Control departments and CMO/CRO Assay development and troubleshooting Subject Matter Expert (SME) for Quality Control molecular imaging systems Perform analytical assays for qualification, validation, and method transfer including Biacore, cIEF, ELISA, and SDS-PAGE.
07/2006 to 01/2012
Principal Quality Control AnalystMarquette University – Milwaukee, WI,
Responsible for the testing of in-process and bulk drug products for stability and release Identification and evaluation of molecular imaging systems (Kodak/Bio-Rad/Fuji) for gel and dot blot assays and the training and transfer of imaging capabilities to CMO Write, revise, and review SOPs, transfer reports, IOPQ reports in accordance to cGMP guidelines and ACH requirements Support global Quality Control departments by troubleshooting assays and the preparation of controls and standards Assay technical transfer to Quality Control departments Analytical assays include: RP-HPLC, cIEF, Phastgel IEF, ELISA, and Biacore Monoclonal antibody purification and biotinylation.
09/2005 to 05/2006
Quality Control SupervisorDanaher – Fremont, CA,
Supervision of Quality Control analysts in the Protein Production Laboratory (PPL) Generate testing schedules for bulk drug products, in-process, and stability samples for the Microbiology, Analytical and Raw Materials departments Primary Quality Control liaison between QC and Purification, Cell Culture, R&D and QA Departments cGMP review of Microbiology, Analytical and Raw Material data for product and component release Write, revise and review SOPs, qualification protocols and qualification reports in accordance to cGMP guidelines and ACH requirements Perform OOT/OOS/OOL investigations Perform Alert/Action investigations Responsible for year-end employee reviews and establishing annual goals for all QC employees.
09/2002 to 07/2004
Adjunct ProfessorCake Enterprise – Newport Beach, CA,
Lecture and laboratory, 50 students.
Immunology: Lecture and laboratory, 19 students.
07/2002 to 09/2005
Lead Quality Control AnalystWaters Corporation – Unavailable, MI,
Responsible for the testing of in-process and bulk drug products.
Write, revise and review SOPs in accordance to cGMP guidelines.
Assay development, troubleshooting, technical transfer from the Protein Chemistry and Analytical Development departments Analytical assay transfer to project CMO FDA/EP pharmaceutical regulations Analytical assays include: ELISAs (Host Cell Protein/Protein A/Immunoreactivity), residual DNA, IEF, HPLC(rPA/SEC), BCA and Bradford Total Protein Assays.
12/1999 to 09/2000
Technical Support AssociateEndogen-Pierce, Inc – City, STATE,
Responsible for the production and testing of monoclonal and polyclonal antibodies.
Performed biotinylation of monoclonal antibodies.
Preparation of Fluoroscein-5-Isothiocyanate (FITC) labeled antibodies.
Small scale protein purification Initiated and participated in projects aimed at the replacement of mercury-based preservatives from assay kit components.
09/1998 to 12/1999
Manufacturing TechnicianEndogen – City, STATE,
Responsible for the formulation of antibody dilution buffers, HRP concentrates and microplate coating, blocking and stabilizing solutions.
Large scale production of 96-well ELISA microtiter plates.
Operated and maintained an Oyster Bay Microplate Coating System (M.P.C.S - 10) in class 100/100,000 clean-room.
Filled, labeled and packaged finished products for Quality Control approval and release.
Fellowships and Awards
Publications
Papers and Lectures
Memberships and Affiliations
American Society for Quality (ASQ) - 2015
Member of the North East Quality Council
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