Quality Assurance Medical Device
Resume:
**** ***** **** **., ****** Park, Florida *****
Nikole T. Goldsmith
E-mail: **********@***.*** Cell Phone: 904-***-****
OBJECTIVE:
Seeks career opportunity that would allow the utilization of my knowledge and expand on my experiences.
EXPERIENCE:
NuScience Consulting and Management Group – Jacksonville, FL (09/2010 to Present)
Consultant
• Perform both Quality Assurance & Quality Control functions
• Developed and Implemented organizations Quality System in accordance with FDA, and ISO Standards
13485, 10993, 11135, and 11137.
• ISO, ANSI/AAMI Standards
• Quality Management System Developing
• Auditing in accordance with FDA and ISO regulations/Technical Writing
• Facilitate Sterility/Sterilization Validations
• Facilitate Microbial and Fungal Testing
• 510K/PMA Submissions
• Microbiology Functions
PSS World Medical, Inc. - Jacksonville, FL (08/2011-08/2008)
Quality Assurance Specialist
• Perform both Quality Assurance & Quality Control functions
• Developed and Implemented organizations Quality System in accordance with FDA, and ISO Standards
13485, 10993, 11135, and 11137.
• ISO, ANSI/AAMI Standards.
• Perform auditing of branch, customer, sourcing agents, and vendor activities through review of electronic
data and site visits to ensure actions meet quality system requirements.
• Coordinate and submit registration of medical device documents such as 510Ks
• Perform incoming test and inspection function for private labeled and branded products – independent
third party testing performed when necessary.
• Train Personnel on Quality Procedures
• Review product packaging and labeling in accordance to appropriate regulatory requirements.
• Maintain Sterility and Sterilization testing and Validation
• Biocompatibility testing
• Perform monthly inspection and testing of high volume products
• Evaluate primary and secondary source vendors prior to entering into contractual agreements
• Product Review
• Develop and maintain required Standard Operating Procedures, Work Instructions, Product and Quality
Specifications and other applicable documentation.
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3135 Tower Oaks Dr., Orange Park, Florida 32065
Nikole T. Goldsmith
E-mail: **********@***.*** Cell Phone: 904-***-****
• Administer document management and change control process to ensure quality activities are compliant
with FDA QSR.
• Complaint handling
• Review customer product feedback and perform corrective actions as required.
• Communicate with vendors to ensure a thorough investigation of complaints is conducted.
Concorde Career College - Jacksonville, FL (10/2010-07/2010)
Adjunct Instructor-Microbiology
• Teaches material from approved curriculum in accordance with assigned schedule to ensure student satisfaction.
• Develops lesson plans to include instructional aides.
• Assists students in achieving completion of objectives. Provides regular and timely feedback to students.
• Participates in school retention initiatives by maintaining productive contact with students and by getting in touch
with and offering assistance to absent students.
• Advises students in matters related to academics, attendance and behaviors.
• Motivates students to actively participate in all aspect of the educational process.
• Maintains and reports student grades and attendance in accordance with college policies.
• Completes professional development with college standards.
University of Florida-Florida Biologix - Alachua, FL (09/2008-01/2007)
Senior Biological Scientist-Quality Control
• Maintain laboratory in conformance with cGMP requirements, ISO 9001 and FDA medical device and
pharmaceutical guidelines (CFR 210, 211, and 820).
• Water Quality Testing, organism (bacterial and fungal) identification, calibration, and validation of equipment and
assays
• Environmental monitoring of viable and nonviable air
• Hands on experience in the performance of a variety of biological product assays, including gel electrophoresis,
PCR, DNA analyses, RFLP, SDS Page, ELISA, spectrophotometric assays for protein, DNA, tissue culture based
assays - titers, endotoxin, sterility, etc. Hands on experience with assay qualification, SOPs, RMS documents, and
Protocols
• Maintain accurate laboratory records, including data and file management
• Train lab technicians and Biological Scientist
• Perform analyses for the timely testing of clinical-grade biopharmaceuticals
• Train lab technicians and Biological Scientist
• Prepare samples for contract testing
Vistakon, Johnson & Johnson - Jacksonville, FL (01/2007 – 03/2006)
Associate Scientist - Quality Assurance
• Maintain laboratory in conformance with cGMP requirements, ISO 13485 and FDA medical device guidelines
(CFR 210,211,and 820).
• Prepare test protocols and final reports for research and validation projects pertaining to microbiological control
and sterilization
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3135 Tower Oaks Dr., Orange Park, Florida 32065
Nikole T. Goldsmith
E-mail: **********@***.*** Cell Phone: 904-***-****
• Conducted GMP audit of supplier
• Generated monthly and quarterly reports with trend analysis for environmental monitoring product/component bio-
burdens.
• Developed new sanitization procedures and revised existing ones as required
• Assisted with Sterilizer Validations
• Responsible for oversight of testing activities such as: Microbial Identification test (Bacteria, Yeast, and Molds),
Sterilization re-qualifications
• Environmental monitoring samples for the presence of bacterial or fungal contamination
• Water quality testing
• Media preparation and media QC
• QA documentation, data review, writing SOPs
• Aseptic transfer of microorganisms
Apptec - Marietta, GA (09/2005 – 05/2005)
Sterility Technician
• GLP, GMP, FDA medical device and pharmaceutical regulations
• Quality Assurance Laboratory
• ISO 13485, CFR 210, 211 and 820
• Environmental monitoring in clean room
• Medical device testing, clean room, package testing, biological indicators, liquid sterility test, product sterility test,
and inoculated product test
Centers for Disease Control and Prevention - Atlanta, GA (09/2005 – 09/2003)
Emerging Infectious Disease Fellow
• Evaluated and revised three PCR assay protocols based on FDA regulations
• Used AP-PCR assay to distinguish molecular markers of Streptococcus pneumoniae from Streptococcal
conjunctivitis and atypical S. pneumoniae
• Developed a nested PCR for PsaA PCR assay
• Evaluated Sensitivity and Specificity in PCR assays
• Developed a protocol for the extraction of Buffy Coats to test for S. pneumoniae
• Performed ELISA on human and bacterial samples
• Western/Southern Blot Analysis
• Tissue Culture Techniques
• Wrote PCR Standard Operating Procedure
• Perform Adherence Assays for inhibition of adherence to human nasopharyngeal epithelial cells by anti-PsaA
antibodies
• DNA, RNA extractions
• Real-Time PCR
• Gene Sequencing
EDUCATION:
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3135 Tower Oaks Dr., Orange Park, Florida 32065
Nikole T. Goldsmith
E-mail: **********@***.*** Cell Phone: 904-***-****
Bachelor of Science-Microbiology/Clinical Laboratory Science w/ Microbiology Emphasis
• Northern Michigan University – Marquette, MI
Masters of Business Administration
• University of Phoenix – Phoenix AZ
MILITARY SERVICE:
United States Navy
OTHER QUALIFICATIONS:
Clinical Lab Science Experience: Chemistry analytes using Vitro and Vitro ECI, HPLC, Turbidity, Infrared
Spectrophotometer, Phlebotomy, complete blood counts and coagulation testing, blood typing and Rh factor
testing
Computer skills: in Microsoft Excel, PowerPoint, and MS Word
PROFESSIONAL MEMBERSHIPS:
• American Society for Microbiology
• American Society for Quality
ABSTRACT/POSTER PRESENTATION:
• Goldsmith, N.T., Messmer, T., Sampson J., Carlone, G., F. Facklam. Is Arbitrarily Primed PCR a Useful Tool in
Discriminating Streptococcus pneumoniae from other Upper Respiratory Tract Streptococcus in Clinical Isolates,
ASM General Meeting 2005, Atlanta, GA
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