R D Quality Control
Resume:
Amy N. Sullivan MBA
************@*****.***
US Central Time
CORE COMPETENCIES
Multidisciplinary Team Lead / Operations: SJCRH Research and Clinical Departments and Merck & Co., Inc.
Pharmaceutical and Biotech: cGMP / GLP / USP / EP / NF / Microbiologist II / Sterilization / Microbiological Testing / Raw Materials / Finished Goods / USP Water / WIP / Technical Writing / Material Assessments / Material Validation / SOP / Software proficient / Training Certifications Merck / Proficient use of laboratory instrumentation
Quality Control and Assurance: Adverse Event, CFIT Investigations / CAPA / NOE / TOC / Validation / Audits / Trend Analysis / discovered waterborne contaminant Ralstonia Insidiosa in pilot system Merck & Co., Inc.
Life Science: Microscopy, Sterilization Methods / Assay technology / R&D / Biochemistry / Radiation / Molecular Biology technology DNA and RNA / Sub-cloning and site-directed mutagenesis / Transduction / Transformation / Primer design and Vector technology / DNA Sequencing / PCR / Virology technology / Protein expression / purification / Mass spectrometer / Spectrophotometry / Liquid chromatography / SDS-Page / MCAC technology / TLC / Tissue Culture technology / Contamination control / Hazardous Waste
Computer proficient in Microsoft Office Professional, Windows 7, 10, MS Word, MS Excel, MS PowerPoint, MS Outlook, Molecular Biology Software, NCBI, CRLIMS, (Consumer Research Laboratory Information System), MIDAS, Track Wise
EDUCATION
Master of Business Administration, (M.B.A.) Health Services Administration- GPA 4.0
October 2009 – March 2011
Strayer University-Memphis, TN
Bachelor of Science, (B.S.) Microbiology and Molecular Cell Sciences- May 1996
Bachelor of Arts, Psychology, (B.A.) - December 1994
University of Memphis-Memphis, TN
NOTABLE ACCOMPLISHMENTS
Commended by GSK / Parke Davis / National Institute of Health (NIH)
Aided in discovery of substrate-independent enzyme using Assay technology
Discovered waterborne pathogen in pilot water at EDI point of use
Acknowledged as “Technical Expert” in numerous scientific journals
PROFESSIONAL EXPERIENCE
Private Home Care Provider Apr 2014 –Oct 2023
Cared for ailing elderly parent until death.
Worked part-time jobs at: FedEx, Best Buy
MERCK & Co., Inc. Memphis TN Mar 2011 – Sept 2014
Microbiologist II, Associate (Astrix Contract)
Merck Consumer Care R&D
Microbiology: cGMP Testing: Environmental Monitoring, Microbial Isolation, Plate Counting, Gram Stain, Microbial Limits Test (MLT), Antimicrobial Preservative Effectiveness Testing (AET) and (AET EP) Growth Promotion, Bioburden, Viable particulate analysis, Non-viable particulate sampling, Bowie Dick, TOC, LAL Endotoxin and Rate-of-Kill. Test raw materials and finished products, USP,EP,NF
Quality Assurance and Regulatory Compliance: Write, review, edit and execute all Technical Assessments, SOPS, Validation, and Final Reports. CFIT, CAPA, NOE Root cause and resolution of investigations across varying departments.
Quality Control: USP Purified Water - Discovered Ralstonia Insidiosa, a contaminant in water system
Sterilization: WET heat -Autoclave, DRY heat, Filtration, Electromagnetic Radiation-UV,gamma trained, 70%EtOH / IPA Solvents, (EPA) registered disinfectants
Operations: Contamination control, maintenance of all Incubators, Refrigerators, Chart Recording, Laminar Air Flow and Biological Safety Cabinets, excellent use of Microscope.
Additional: Interviews potential candidates for appropriate lab positions and executes training for the selected candidate(s).
Strayer University Student Support Associate Mar 2011 - 2012
Strayer University Full-Time Student / Accelerated Program Oct 2009 - 2011
Assisted both Undergraduate and Graduate with core courses suitable and required
for program completion. I encouraged and motivated students with emphasis on the benefits of higher education and accomplishing their pursuit of success of self-accomplishment
St Jude Children’s Research Hospital- Memphis, TN Nov 2006 – Aug 2009
Clinical Research Associate, CRA Division of Bone Marrow Transplantation and Cellular Therapy / and The Children’s Oncology Group / Comprehensive Cancer Center Administration
Healthcare Administration in I, II, III, IV clinical trials
Maintained the management and monitoring of patients >38 studies both in-house and multi-institutional trials and external affiliates
Abstracted, assembled, recorded data in medical record charts from Eligibility, Consent to Death, all medications, chemo and radiation, pathology, imaging, adverse events, audits and participation in mandatory Doctor’s rounds
Demonstrates working medical knowledge and terminology of the appropriate applications in clinical research. Including and not limited to, conducts, laws, regulations, standards, and compliance with applicable SOPs and policies.
St. Jude Children's Research Hospital-Memphis, TN Oct 2000- Nov 2007
Senior Scientist / Sr. Research Technologist – Department of Infectious Disease Division/Virology
Managed numerous research projects simultaneously with little or no supervision.
Effectively managed laboratory operations holding three laboratory Officer positions over 18-22 colleagues, Radiation Safety Officer, Hazardous Waste and Chemical Hygiene Officer, Authorized and approved Grant Purchasing Officer
Round table discussions of work completed, work in progress and the addition of new projects
Publication quality data
Assay technology / R&D / Biochemistry / Radiation / Microbiology / Molecular Biology technology DNA and RNA Sub-cloning and site-directed mutagenesis / Transduction / Transformation / Primer design and Vector technology / DNA Sequencing / PCR / Agarose gels / Virology technology / Protein expression / Protein purification / Western / Northern Blot / ELISA / Mass spectrometer / Spectrophotometry / Liquid chromatography / SDS-Page / MCAC technology / TLC / Tissue Culture technology / Hazardous Waste / Proficient use of laboratory chemicals and instrumentation
St. Jude Children's Research Hospital-Memphis, TN Oct 1997-Oct 2000
Research Technologist – Department of Biochemistry (merger into Department of Infectious Disease)
Promoted to Senior status
Additional Information can easily be provided by request.
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