Manager Project
Resume:
Shalonda Smith
Birmingham, Al 35212
************@*****.***
EDUCATION AND CERTIFICATION
Alabama A&M University, Normal, AL
BS May 1999, Biology/with concentration in Chemistry
Alabama A&M University, Normal Al
Graduate School 2000
Alabama State University, Montgomery, AL
Next Level Entrepreneurship Course 2003
Certified Forensic Scientist by the State of Alabama
Member of the American Chemical Society
Security Clearance
PROFESSIONAL EXPERIENCE
Eathian LLC. October 2007-August 2010
Office Manager/Project Coordinator
-Oversee the work of associates assigned to the project team for specific task assignments.
-Monitor project deliverables and timelines, notify the Project Director when issues arise, and take
corrective actions, as needed.
-Document activities and develop feedback report to communicate project findings and activities to
collaborators and others involved.
-Develop reports and other deliverables as assigned by the Project Manager.
-Provide regular written and oral reports of activity on assigned contracts.
-Track office expenses and create monthly reports for office.
-Prepare invoices, accounts receivable/payable and banking.
-Prioritize and delegate tasks, provide motivation and direction to create a positive work environment
and ensure accurate, on-time completion.
N. Giovanni Bonner & Associate Attorney at Law June 2007-September 2007
Office Manager/Personal Assistant
- Provided continuous, high quality support.
- Coordinated schedule appointments and travel arrangements.
- Proofed and edited complex documents
- Tracked office expenses and created monthly reports for office.
- Prepared invoices, Accounts Receivable/Payable and banking.
Hook & Son’s Auto Paint &Body Shop December 2006-May 2007
Office Manager
- Coordinated work flow among five staff members.
- Prioritized and delegated tasks, provided motivation and direction to create a positive work environment
and ensured accurate, on-time completion.
-Tracked office expenses and created monthly reports.
Élan Pharmaceutical Inc. June 2006-November 2006
Metrology/Analyst I
-Develop and evaluates calibration systems that measure characteristics of objects, substances, or phenomena,
such as length, mass, time, temperature, electric current, luminous intensity, and derived units of physical or
chemical measure.
-Identifies magnitude of error sources contributing to uncertainty of results to determine reliability of measurement
process in quantitative terms (root cause analysis).
-Redesigned or adjust measurement capability to minimize errors.
-Developed calibration methods and techniques based on principles of measurement science, technical analysis of measurement problems, accuracy and precision requirements.
-Direct engineering, quality, and laboratory personnel in design, manufacture, evaluation, and calibration of
measurement standards.
-Calibrated Analytical Balances
-Calibrated Dissolution Baths, and maintenance baths.
-Calibrated pH Meters is an example of an in-line analyzer, (DCS control system element)
-Applied statistics, statistical sampling, statistic processing control and auditing (tagged out or tagged in method)
principles routinely.
-Test systems to ensure selection of approved instrumentation.
-Insured company, Federal Food, Drug and Governmental regulatory compliance.
-Worked with Methods Lab to ensure that the transfer of validated analytical methods are sufficiently rugged to
give accurate and reliable results when performed by the various shift personnel.
- Performed a daily overview status report of lab investigations to ensure timely and reliable information to the
various production units.
-Reviewed current SOPs for the QC Laboratories, including equipment operating manuals, calibration procedures
and preventive maintenance procedures. Directed timely revisions of these documents as required.
- Coordinated the establishment of test limits, validation protocols, testing and final reports in a timely manner.
- Coordinated the calibration of all production and laboratory scales for all sites. Review and complied all reports.
-Review and approved in-process investigations of problematic assays results. Ensured appropriate communication
with the QA/QC of all investigations. Communicate problematic assay results that may delay product release to
production units and elicit any and all information that is required to determine if the problematic assay results are
process or analytical in nature.
- Participated in company meetings and committees as needed or required, (oral, written, and presentation).
-Working knowledge of QSR, GLP, GCP, GTP, followed CGMP regulations.
-Strong experience in disassembly, and reassembly of test equipment and followed functional testing protocol.
-National Institute of Standards and Technology compliance ensuring quality control.
-Follow ups with Certificates of Calibrations issued for every calibration. Data sheets of actual readings kept
available on file.
-Calibration labels showing date calibrated, date due, serial number and technician are affixed to all items calibrate
-Notified company when their equipment was due for calibration, sent notices mailed at least two weeks in advance
and called for confirmation.
-Vibration Meter
-Tachometer
-Wobble Gauge
NIOXION Research Laboratories, Inc. February 2005-June 2006
Research Analyst
-Analyzed, interpreted, and wrote Standard Operational Procedure.
- Set up library for High Pressure Liquid Chromatography.
- Oversaw the monitoring of products by testing samples from each Fill Line.
- Regulatory coverage of all aspects of production and distribution of active pharmaceutical ingredients(APIs) to
assure the products comply with the Federal Food, Drug and Cosmetic Act (the Act).
- Secures micro samples, plate samples, prepared media, analyzed plates, and record data.
- Maintain inventory reports and logs accurately.
-Advanced analytical, problem solving and organizational skills.
- Look for ways to improve and promote quality performance, manages competing demands; changes approach or
methods to best fit the situation.
-Ability to calculate figures and amounts such as discounts, interest, commissions, proportions, percentages, area,
circumference and volume. Ability to apply concepts of basic algebra and geometry.
-Reorganized laboratory to support increased production, new validation projects and improve compliance.
-Calibrated Analytical Balances
-Moisture Calibration
-pH Meter Calibration is an example of a in-line analyzer, (DCS control system element)
-Pipeting Calibration
-Calibrated industrial weighing equipment, including bench, floor, and pallet scales.
- Preventative maintenance techniques.
United Douglas Pharmaceutical Inc. January 2004 –February 2005
Quality Control Analyst
-Analyzed calculated Data( Mean and Standard Deviation)
-Maintenance of appropriate documentation (records and lab notebooks) as required by SOP’s.
-Maintenance the lab
-Calibrated Analytical Balances
-Moisture Calibration
-TOC Analysis
-Pipeting Calibration
-pH Meter Calibration
-Water Sampling and Testing (pH reading) is an example of an in-line analyzer, (DCS control system element).
-Followed USP regulations for testing on dietary supplements and unknown samples.
-E.coli testing
-Test raw materials, in-process, finished products and stability programs in a manner that ensures
accurate and expedient results in compliance with company and customer specifications.
-Experience in microbiological and facility environmental monitoring
processes.
-Directed the review and approval of test methods and protocols to ensure the use of reliable and validated
methods in Analytical Chemistry, Raw Materials and Microbiology.
-Prepared Media
-Cleaning validation programs, statistical process control based production planning
-QC laboratory management, analytical chemistry, clinical reagent development.
-Responsible for division wide quality operations including product release; regulatory affairs liaison with FDA
and international agencies; facility, process and product validation; document control, microbiology laboratory,
facility environmental monitoring, internal compliance and auditing.
- Directed product test and release program, stability programs, and product validation testing.
-Automated vial filling line, process validation audits, FDA compliance, analytical instrument validation,
generic solid dosage manufacturing, modified release solid dosage, tablet and capsule manufacturing processes
validation, process failure resolution, aseptic filling facilities, regulatory compliance, API cleaning validation,
filtration process validation, analytical and microbiology laboratory audits, and new equipment integration.
-Extensive sterilization processes, clean in place, product sample analysis, raw material analysis, product stability.
-Developed statistical procedures and report format for the validation of immediate release tablet and capsule
manufacturing processes.
-Responsible for the analysis of all bulk and finished product release samples, raw materials, product stability and
complaint samples. Laboratory investigation of out-of-spec results, problem investigation, method transfer,
method development for product troubleshooting, qualification of secondary reference standards, audits.
-Managed the Quality Control and Quality Assurance functions for the manufacture of solid dosage forms and
suspensions. Responsibilities included: all analytical and microbiological laboratory functions, internal audits,
external audits, batch release, problem and deviation investigation, CGMP training.
-Advised an API manufacturer on the development of a cleaning validation program for a multi-product facility.
From May 2001-October 2004 relocated to Alabama to care for sick family member.
Analytical Services, Inc. February 2001-May 2001(contracted)
Semi-Volatile Extractionist
-Worked extensive overtime
-TCLP Procedure(Toxicity Characteristic Leaching Procedure)
- Herbicides Extractions
- Aqueous Extractions
- PEST/PCB Extractions
- Static test protocol development
- Followed established procedures to perform extractions on water and soil samples. Then concentrated samples for chemist to analyze.
-Calibrated Analytical Balances
-Calibrated pH Meter is an example of a in-line analyzer, (DCS control system element)
-Moisture Calibrations
-Maintenance the lab
-Preventative maintenance techniques.
American Red Cross October 2001-November 2001 (contracted)
Laboratory Technician
-Followed Code of Federal Regulations (CFR)
-American Red Cross Biomedical Services directives and
local policies and procedures.
-Learned special serologic techniques.(Terumo-TSCD Sterile Tube Welder Dock the bags unto red cells, Bags used called Pall Leukotrap, SCRC take white blood cells out of red cells, Sarstedt BT 300 6 head sealer use machine make segs, Sorvall RC 3BP Centrifuge use to spin blood)
-Calibrated pH Meters a in-line analyzer, (DCS control system element)
-Moisture Calibrations
-Maintenance the lab
- Preventative maintenance techniques.
Administrative Assistant III November2001-December 2001 (contracted)
-Developed work methods and scheduling priorities.
-Prepared and edited complex documents( Assisted in the preparation of power point presentations)
-Assisted with preparation of the department’s procedure manual.
-Organized and maintained FDA-regulated records.
-Handled limited issues in manager’s absence.
-Helped with managing projects in a timely manner.
Paragon Trade Brands Research and Development June 2001-August2001 (contracted)
Research Technician/Tensile Tester
-Compared products using standard testing method (calibration).
-Used and calibrated Multi-meters, multi-function calibrators, and high accuracy resistance standards.
-Preventative maintenance techniques.
-Redesigned or adjust measurement capability to minimize errors.
-Research and analyzed data.
-Maintenance the lab
Chemistry Research Assistant June1997-May1999
Dr. James Thompson, Professor of Chemistry, Alabama A & M University (Normal, AL)
- Organized labs, lectured, and evaluated students in laboratory sessions for introductory chemistry courses.
- Organized lectures, homework, and readings, lectured, and evaluated students in course homework.
- Maintenance the lab
Skills: Proficiency in Microsoft Word, Word Perfect, Microsoft Excel, Power Point. Experience with PC's and
Mac's; html and some Java programming. word processing, process simulation, project management, and
mathematical applications; customize it and provide some troubleshooting.
INSTRUMENT KNOWLEDGE
- Mass Spectrum, FTIR, and Chromatography
- TOC Analysis
- Moisture Analysis Oven/Halogen Moisture Analyzer
- Analytical Balances (Weights)
- Samples Analysis
- Coagulase Test
- Calibrate Machines
- Higher Performance Liquid Chromatography (HPLC)
- Gas Chromatography example of an on-line analyzer, (DCS control system element)
- OPRON-3000 UV/VIS Spectrophotometer
- Thermo Orion pH Meter
- Mettler Toledo DL31 Karl Fischer Titrator
- Water Baths
- Colony Counter
- Linos Photonics
- IR Spectrophotometer
- Sam Sung Hydraulic Machine
- Incubators
- Prepare agar
- Electron Microprobe
- Scanning Electron Microscope
- Optical Microscope
- Vibration Meter
- Tachometer
- Wobble Gauge
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