CAREER PROFILE

Experienced Chemist and Quality Assurance Specialist with various laboratory skills which include wet chemistry techniques, HPLC, GC-FID (Agilent), Atomic Absorption (Flame), Graphite furnace atomic absorption and *working knowledge of GC-MS (Agilent). I possess private sector Quality Control experience in a very fast paced production environment allowing me to thrive as an individual or within a team. These skills allow me to complete any task that promotes the well-being and upward mobility of said company or corporation.

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Project and Program Leadership

Communications

Conflict Management

Editing

Public Health Relations

Troubleshooting

Government Solutions

Inventory

Policy Administration

Research

Development

Quality Assurance

Quality Control

Instrumentation

Pharmaceutical Manufacturing

Auditing

Regulation

Chemist

cGMP / cGDP/cGLP

Analyst

PROFESSIONAL EXPERIENCE

Catalent Pharma Solutions

Senior Associate Scientist Morrisville, NC July 2016 – Present

Serve as a Scientist directly supporting in-process and final product release of inhalation pharmaceutical goods manufactured in-house as well as participation in quality reviews and audits.

Execute Instrumentation including HPLC (Total Chrom), GC (Total Chrom), GC/MS (Total Chrom), Infrared Spectroscopy, Karl Fisher, pH, Spray View, Hiac/Particle Counter, Particle Size PSD Polarimeter and Colorimeter.

Standardization/Calibration Checks of solutions instruments and balances.

Provide data entry and review as required.

Provide summaries of test results to appropriate personnel

Directly support Process Simulations and Performance Qualification activities.

Assist in development of Quality Notifications

Present deviations at deviation notification meetings.

Review Out of Spec (OOS) sample results and notify Management of production impact.

Perform sample accountability.

Preform investigation activities (root cause analysis, hypothesis testing, Trackwise entry)

Participation in Kaizen events(5/S).

Conduct Batch Record Review

SOP draft, author, revisions and review.

21 CFR part 11

Participation of regulatory inspections, audits, validation activities within QC Laboratory.

Lean Six Sigma (White Belt Certified)

Support Instrument onboarding activities completed by outside vendors

Pfizer

Senior Quality Control Chemist Rocky Mount, NC February 2014 – July 2016

Serve as a Quality Control Chemistry Analyst directly supporting in-process, raw material and final product release of injectable pharmaceutical goods manufactured in-house.

Conduct analysis on Finished Products/In-process goods according to current testing procedures following GLP, ICH, EP, JP, USP, FDA, DEA and GMP guidelines including manual titrations and various wet/identification tests

Execute Instrumentation including HPLC/UPLC (Empower), GC (Empower), TOC, Ion Chromatography (IC), (AA) Atomic Absorption (Flame), Graphite furnace atomic absorption, UV Vis, IL Flame Photometer, Infrared Spectroscopy (IR), Karl Fisher, Polarimeter and Colorimeter.

Standardization/Calibration Checks of solutions, instruments and balances.

Provide data entry and review as required.

Provide summaries of test results to appropriate personnel as needed.

Directly support Process Simulations and Performance Qualification activities.

Assist in development of Quality Notifications

Present deviations at deviation notification meetings.

Review Out of Spec (OOS) sample results and notify Management of production impact.

Perform sample accountability.

Execute sample result entry and review in LIMS/Trackwise.

Participation in Kaizen events.

Conduct Batch Record Review

SOP revisions and review.

21 CFR part 11

Participation of regulatory inspections, audits, validation activities within QC Laboratory.

Merck Pharmaceuticals

Associate Specialist, Quality Systems and Compliance Durham, NC August 2013 – February 2014

Execute environmental sampling of classified areas for per-process pharmaceutical manufacturing of vaccines as well as the development of quality reviews and notifications as events occur.

Active air sampling, surface sampling and non-viable air sampling.

Provide data entry and review.

Provide summaries of test results to appropriate personnel.

Evaluate environmental data for adverse trends.

Directly support Process Simulations and Performance Qualification activities.

Perform routine monitoring of Personnel.

Perform data review for Critical Site Review.

Author and assist in development of Quality Notifications (QNs).

Present deviations at deviation notification meetings.

Review OOS report daily and notify Quality and Operations of required steps following OOS.

Perform quarterly microbial testing and provide results/performance to Operations.

Compile and approve Annual Reviews.

Execute and approve LIMS sample rejections.

Participation in Kaizen events(5/S).

Conduct Batch Record Review

SOP revisions and review.

21 CFR part 11

Direct support of regulatory inspections, audits, activities and all other associated Quality functions.

North Carolina Dept of Environmental and Natural Resources

Chemistry Technician III Raleigh, NC June 2007 – August 2013

Extraction and Analysis of volatile, semi-volatile, pesticide, inorganic and herbicide compounds from water, fish and soil samples collected from public and private lands around the state of North Carolina.

Analyze and report extracted Pesticide/Herbicide water, soil, and fish samples utilizing

Gas Chromatographs (GC) equipped with a Flame Photometric (FPD),{Chem Station}

Electron-capture (ECD), Nitrogen Phosphorus Detectors (NPD){Total Chrom}and *GC/MS

Screen extracted water and soil samples for Semi-Volatile and Volatile organic compounds utilizing a Gas Chromatograph equipped with a Flame Ion Detector (GC-FID)

Utilize Gel Permeation Chromatography (GPC) and Florisil Clean-up for fish tissue

Quantization of Total Kjeldahl Nitrogen (TKN) Copper Catalyst/Block Digestor Method/ Total Phosphorus (TP) Acid Persulfate Digestion Method and Nitrites in surface and waste water by flow injection analysis colorimetry and TOC.

Preparation of standards, reagents and dilutions, updates of SOP’s, Documentation of procedures in Lab Notebooks, clean glassware, sample check-ins, pH testing, scale and instrument calibrations, sample prep, change gas tanks used with GC instrumentation, troubleshooting instrument and lab equipment problems, Data Review/QA/QC.

BASF – BPS Agriculture Products

Chemistry/Media Lab Technician RTP, NC December 2006 – June 2007

Work in conjunction with agriculture transformation groups to assist with the development of new agriculture products.

Preparation of slurries/ media using to assist in the completion of the agriculture transformation growth process

Utilize “sterile techniques” to insure the sterility of the final products

Autoclave – pH testing – preparation of stock/standard solutions -instrument calibration

North Carolina Dept of Environmental and Natural Resources

Chemistry Technician Raleigh, NC May 2006 – December 2006 (Internship)

Extraction/Digestion and Analysis of Inorganic compounds from water, fish and soil samples collected from public and private lands around the state of North Carolina.

Quantization of Total Kjeldahl Nitrogen (TKN) Copper Catalyst/Block Digestor Method/ Total Phosphorus (TP) Acid Persulfate Digestion Method and Nitrites in surface and waste water by flow injection analysis colorimetry and TOC.

Preparation of standards, reagents and dilutions, updates of SOP’s, Documentation of procedures in Lab Notebooks, clean glassware, sample check-ins, pH testing, scale and instrument calibrations, sample prep, change gas tanks used with GC instrumentation, troubleshooting instrument and lab equipment, Data Review/QA/QC.

North Carolina Dept of Environmental and Natural Resources

Environmental Waste Manager (intern) Raleigh, NC August 2004 – August 2005

Traveled the state of North Carolina to complete the task of validating and plotting NC Radiation licenses holders locations and materials. Worked with Incident/Emergency Response Team to gather radioactive material not documented for lawful use and containment of radioactive spills.

Assist in a team project by traveling across NC to gather data points on Radiation Licenses holder’s locations by use of a state vehicle and operation of GPS and GIS instruments

Assist with the organization of a safety-training programs conducted by Radiation Protection Section.

Assist in gathering materials and data with Incident/Emergency Response Teams around NC

EDUCATION

North Carolina Central University Durham, North Carolina

Bachelor of Science (B.S.), Chemistry December 2005

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