Manager Quality Assurance

Julie Anna Decker

I am a self motivated and driven chemist that desires employment that will challenge my abilities and knowledge.

Career Summary

I attended the University of Louisville and acquired my Bachelors of Science in Biochemistry and Molecular Biology. I went on to get my Masters Degree in Chemistry at the University of Louisville and worked as a Cardiology research chemist. Upon leaving the University of Louisville in 2007, I began employment with AAPER Alcohol and Chemical Company as a Regulatory Coordinator and ISO Specialist. I created and implemented the ISO program during my first 6 months at AAPER, from Quality Manual to SOPs to Work Instructions to Forms/Training Modules. I was involved in all aspects of ISO9001:2000 and ISO9001:2008 from auditing, statistical analysis, and management involvement. I was promoted to Laboratory Manager in 2008 where I ran the Quality Control laboratory and the Quality Assurance functions, in addition to my regulatory duties and ISO Coordinator Functions. I managed two chemists and two document control specialists. In 2009 I was promoted to Quality Control/Quality Assurance Manager and EHS/Regulatory/ISO Manager for AAPER Alcohol. I am involved in all aspects of the manufacturing process and act as a batch chemist for production in addition to managing the laboratory and regulatory/ISO functions. I am knowledgeable in Alcohol and Tobacco Tax and Trade Bureau (TTB) regulations, FDA, cGMP, HACCP, EPA/DHS/OSHA regulations and currently manage the EHS and Safety functions for my site. I currently have 4 QC chemists, 5 Batch Chemists, and 3 document control specialists as my direct employees. I am an assertive manager with outstanding interpersonal communication, negotiation, and people management skills.

Personal Information

Born: September 25, 1979; Mayfield, KY

Home: 3400 Lena Rachel Circle, Dacula GA 30019

Phone: 502-***-****

Office/Campus: AAPER Alcohol and Chemical QC Laboratory

PHARMCO-AAPER

1101 Isaac Shelby Drive, Shelbyville, KY 40065

Phone: 502-***-****. Email: *****.*.******@*****.***

Education

1993-1997 Graves County High School, Mayfield KY

1997-2003 University of Louisville, Louisville, KY

B.S. Molecular Biology

B.S. Biochemistry

Minor in Physics and Mathematics

2003-2005 Masters of Science in Chemistry with a concentration in Biochemistry and Microbiology

Job Experience

2007-Current Quality Manager, ISO 9001:2000 Manager, GMP Manager, Batch Chemist, Environmental Health and Safety Director, and Regulatory Coordinator.

AAPER Alcohol and Chemical

1101 Isaac Shelby Drive, Shelbyville KY 40065

Phone: 502-***-****. Email: *****.*.******@*****.***

*2008 Employee of the Year for AAPER Alcohol and Chemical

2005-2007 Research Chemist

Department of Environmental Cardiology

University of Louisville School of Medicine, Louisville, KY 40292

Dr. Sanjay Srivastava, Ph.D. 502-***-****

1999-2005 Research Assistant

Kentucky Spinal Cord Injury Research Center

University of Louisville School of Medicine, Louisville, KY 40292

Dr. Stephen M Onifer, Ph.D Cell 502-***-****

Management Skills

• Managing 4 QC Chemists, 5 Batching Chemists, and 3 Document Control specialists in the analysis and development of Regulatory and Quality objectives at a manufacturing facility.

• Responsible for entire ISO9001:2008 Program at AAPER Alcohol.

• Working with European Union mandates for quality product shipped overseas.

• Experience with ICH Q10 Pharma Quality Systems.

• HACCP certified by AIB International. Responsible for all HACCP mandates.

• Research and Development of Water for Injection 20% Ethanol Blends, Gamma Irradiation of Reagent Alcohols, and Sterile ethyl alcohol blends for sale to Pharma companies.

• Research and Development of Clean room and White room installation (class 10,000) to manufacture sterile ethanol blends and subsequent FDA registration.

• Responsible for all cGMP regulations and compliance.

• Responsible for all internal audits and documentation reports.

• Conducted all safety and security training.

• Assisted in the SPCC filings for my facility.

• Delegated all regulatory and safety mandates and audited the completeness of actions required and upgrades undertaken to ensure compliance.

• IQ/OQ/PQ of all laboratory equipment.

• Lead audit representative for all external audits regarding quality (pharmaceutical audits), safety (OSHA/DOT/EPA), security (DHS), and regulatory issues (TTB, FDA).

• Leading in-house personnel delivering production chemistry support.

• Regulating and co-managing the bottling and bulk line processes (pints, gallons, liters, 5 gallon, 55 gallon, 270 gallon, and 6000 gallon tank truck).

• Instrumental in instituting all new batching regulations as mandated by the Alcohol Tax and Trade Bureau (TTB) 27 CFR, which were put in place as of April 2009 at my facility.

• Leading production chemistry improvements from conception through to execution, working closely with Operations to proactively ensure the delivery of results.

• Coordinating, completing, and testing of batch processing (from both large 15,000 gallon batches to small 5 gallon batches)

• Excellent record of team involvement and motivation.

• Owning and controlling the management of change for production chemicals, including risk assessment & identifying mitigating actions.

• Conducting analysis and interpretation of chemical data and information, and communicate the interpretation to other relevant parties in a meaningful way and following through on any recommendations.

• Attending relevant production and operations meetings to identify current and new production chemistry issues.

• Providing chemistry and production chemicals expertise and support to the other functions.

• Conducting on-site internal audits of facility. Ensuring that the information is current and up to date, including audits of operations input.

• Providing technical support for the customer and other departments within the company.

• Conducting periodic reviews of systems.

• Conducting periodic reviews and updates of lab procedures as required.

• Managing all training records and conducting training sessions as well as verification of training.

• Presented quality presentations regarding my facility to parent company quality panel.

Quality Control/Quality Assurance/ISO/Regulatory Skills

• Managed cGMP and cGLP regulations and directives for Pharmco Products and AAPER Alcohol.

• Extensive knowledge of TTB regulations and mandates per 27 CFR.

• Participated in HACCP training and regulations and was responsible for HACCP program at AAPER Alcohol.

• Created and maintained all ISO metrics and all applicable statistical analysis for PHARMCO-AAPER, including posting, binding, and presentation to senior management monthly.

• Monthly review and analysis of all statistics for PHARMCO-AAPER which is also presented to senior management.

• Created and maintained all training records and databases for general training, task-specific training, and safety and security training.

• Revised and/or rewrote ISO program from Quality Manual, Standard Operating Procedures, Work Instructions, Forms, and Test Methods.

• Maintained ISO elements from inception to completion.

• Participated in all ISO auditing procedures, including pre-assessment to 3.5 day initial audit for certification.

• Maintained and facilitated the communication of ISO concepts and training to all staff.

• Performance of validation of equipment and test methods used in the production and analysis of processes and products.

• Developed and assisted in the development of metrics to track departmental performance as well as external customer performance.

• Maintained lab purchasing functions and stocking.

• Maintained all quality files and product files generated at my company site.

• Regularly participated in Senior Management Quality forums.

• Assisted in each mid-year company ISO assessment and book.

• Maintained and responded to Quality matters from Customers in the form of verbal communication or written reports.

• Facility auditor for Quality matters, Environmental Health and Safety matters, as well as all ISO and Government regulations pertaining to Quality and Regulatory,

• Presentation skills with customers and auditors that resulted in addition business or continued business.

Research Skills

Gas Chromatography troubleshooting and technical expertise

FTIR

Coulometer

DMA

UV Vis Analysis

Real Time RT-PCR

ELISA Assays

Chromatography (FPLC, HPLC, Gas, Liquid, Thin Layer, Affinity, and Ion Exchange)

Spectrophotometry

Atomic Absorption Spectrophotometry

EPR Spectroscopy

NMR Spectroscopy

MALDI Mass Spectrometry

Microbiology techniques relevant to macro and micro research

Cell Culture proliferation

Tissue sectioning with freezing microtome, cryostat, and thin sectioning for TEM

Staining with cresyl violet, luxol fast blue, cytochrome oxidase, immunoperoxidase, and immunofluorescent of tissue sections and cultured cells

Light Microscopy

Fluorescent Microscopy

Confocal Microscopy

Transmission electron microscopy

Western blot analysis (SDS-PAGE) of tissues and cultured cells

PAGE analysis

Computer software: Microsoft Word, Excel, and Powerpoint, Adobe Photoshop and Illustrator

Statistical Analysis and Data Reconfiguration of data gathered

Injections and general care of laboratory animals

Research Exposure

Analytical chemical analysis

Statistical analysis using NIH Image

Contusive and lacerating cervical and thoracic spinal cord injury

Peripheral nerve injury

Neuroanatomical tracing: intraneural and intraspinal

Somatosensory Evoked Potential Assessment

Transcranial Motor Evoked Potential Assessment

Open-field locomotion and Grid-walking Assessment

Publications

Massey JM, Hubscher CH, Wagoner MR, Decker JA, Amps J, Silver J, Onifer SM. Chondroitinase ABC digestion of the perineuronal net promotes functional collateral sprouting in the cuneate nucleus after cervical spinal cord injury. Journal of Neuroscience, 2006 Apr 19;26(16):4406-14.

Onifer SM, Nunn CD, Decker JA, Payne BN, Wagoner MR, Puckett AH, Massey JM, Armstrong J, Kaddumi EG, Fentress KG, Wells MJ, Calloway CC, Schnell JT, Whitaker CM, Burke CA, Hubscher CH. Somatosensory Evoked Potential Recovery in Adult Rats after Contusive Cervical Spinal Cord Injury is Associated with Dorsal Column Nuclei Reactivation. Journal of Neurotrauma (submitted).

Onifer SM, Zhang YP, Burke DA, Brooks DL, Decker JA, McClure NJ, Floyd AR, Hall J, Proffitt BL, Shields CB and Magnuson DS. Adult rat forelimb dysfunction after dorsal cervical spinal cord injury. Experimental Neurology, Volume 192, Issue 1. March 2005

Presentations

M Nadar, DJ Conklin, D Gozal, BW Row, J Decker, L Kheirandish, C Uwamariya, S Srivastava, and A Bhatnagar. Chronic Intermittent Hypoxia Affects Composition of Atherosclerotic Lesions in ApoE-NULL Mice. Research! Louisville, Louisville, Kentucky 2006.

JM Massey, M. Wagoner, J. Decker, C. Whitaker, A. Puckett, A. Khalyfa, N. Cooper, SM Onifer. Chondroitin Sulfate Proteoglycan Expression Within the Adult Rat Brainstem Dorsal Column Nuclei, Research! Louisville, Louisville, Kentucky 2005.

BN Payne, MR Wagoner, C Nunn, CC Calloway, JA Decker, J Grey, J Wells, A Puckett, J Schnell, JM Massey, SM Onifer. Rat Dorsal Column Nuclei Are Innervated by Corticofugal, Serotoninergic, and Catecholaminergic Axons, Neuroscience Research Day, Louisville, Kentucky 2005.

JM Massey, B Profitt, M Wagoner, JA Decker, N Mcclure, DSK Magnuson, SM Onifer. Innervation of the Rat Dorsal Column Nuclei After PNS and CNS Injury, Research! Louisville, Louisville, Kentucky 2004.

J Wells, C Nunn, JA Decker, A Puckett, M Wagoner, B Payne, P Fleck, K Fentress, JM Massey, SM Onifer. Analyzing Spontaneous Somatosensory Evoked Potential Recovery after Cervical SCI, Neuroscience Research Day, Louisville, Kentucky 2004.

J Schnell, JM Massey, C Calloway, M Wagoner, JA Decker, LM Wilson, SM Onifer. Anatomy of Adult Rat Forepaw Sensory Neuron’s Dorsal Column Axons, Research! Louisville, Louisville, Kentucky 2003.

JA Decker, J Wells, C Nunn, JM Massey, K Fentress, J Shah, D Burke, B Giamarra, J Schnell, L Wilson, B Payne, M Wagoner, DSK Magnuson, SM Onifer. Assessing Sensory, Motor, and Propriospinal Recovery after Thoracic SCI, Neuroscience Research Day, Louisville, Kentucky 2003.

JA Decker, R West, N Mcclure, M Wagoner, J Schnell, L Turner, JM Massey, SM Onifer. Axonal Growth Within Peripheral Nerve Grafted Cervical Spinal Cord in the Injured Adult Rat, Undergraduate Research Symposium, Louisville, Kentucky 2002.

Professional Affiliations

Student member, Kentucky Academy of Science, August 2000-present

Student member Society of Neuroscience, Louisville Chapter, 2000- present

American Chemical Society Member

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