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Work Background
rose plasticDirector of Quality rose plastic USA
Aug. 2022United States
TolmarSr. QA Laboratory Specialist
Apr. 2020 - Aug. 2022Fort Collins, Colorado, United States
Cook MedicalRegulatory Reporting Specialist
Jan. 2020 - Apr. 2020Winston-Salem, North Carolina, United StatesMedical Device Complaints Assessment, Regulatory Reporting
NovartisDeviation Investigator
Nov. 2018 - Jan. 2020Wilson NC
Baxter International Inc.Quality Engineer
Sep. 2017 - Oct. 2018North Carolina
HospiraQuality Investigator
Sep. 2015 - Sep. 2017Vishakhapatnam Area, India-Conduct and oversee investigations for terminally sterilized products
-Investigation areas of focus: Engineering, Chemistry and Microbiology laboratories, equipment and calibration, procedural gaps, validation failures, method transfer, out of specification Phase I (lab) and Phase II (manufacturing)
-CA/PA (Corrective and Preventative Actions) – improvement to laboratory systems for instrument calibration/qualification, implementation of controls to prevent microbiological contamination of product, procedural simplification
-Mentor investigators and QA team members for technical writing, investigation techniques, identification of realistic CA/PAs, and scope of product impact
-TrackWise
HospiraCQ Investigator/Contract-Quality Engineer
Sep. 2013 - Sep. 2015Clayton, NC-Investigation of OOS results, procedure deviations, and method transfer issues
-CA/PA ownership, change control, training for new changes
-Document preparation
-Audit preparation support
-Metric reporting
-Mentoring of analysts for investigations
MerckTechnical Support Engineer
Jan. 2013 - Sep. 2013Vaccine Manufacturing Facility - Durham, NCDeviation Management Team
Viral Vaccine Technology and Engineering (VVTE) - Bulk Facility
and Vaccine Manufacturing Facility (VMF) Operations
-Investigation of Manufacturing Deviations -Automation Events -Human Error -Environmental Excursions and Environmental Alarms -Instrumentation Malfunctions and Out-of-Tolerance Events -Atypical Batch Record Entries
-Product Impact assessment, knowledge of vaccine manufacturing process
-Author technical reports for Quality Management to assess Product Impact of procedural deviations, atypical events, and equipment failures, Root Cause, and Trending for repeat occurrence.
-Identify and assign CAPAs through collaboration with appropriate functional area
-Experience with Electronic Batch Records and Electronic Log Books (Werum PAS-X)
-SAP for historical trending of events and official electronic signatures for Deviation Reports
-LIMS for EM data analysis and trending and biological release data for batches
-Collection and Number Crunching of key Event Reporting Metrics
-Development of New Hire - System Access Guides, LIMS, SAP, Electronic Batch Records, Process Monitoring Systems
Academic Development GroupTutor
Oct. 2012 - Dec. 2013Cary, NCTutor for Advanced Placement courses: Biology, Calculus, and Chemistry. Tutoring resource for high school students in areas of math and science.
Specialties: Tailored learning, study plan development, core knowledge, crunch time study skills.
PfizerScientist - Biology, High Throughput Screening
Aug. 2012 - Jan. 2013Durham, NC - Pfizer Neusentis-High Throughput Screening (HTS) of potential pharmaceutical compounds against various ion channel targets for drug target activity assessment and development
-Chemical and pharmaceutical formulations, Buffer Preparation
-FLIPR TETRA fluorescent imaging plate reader platform, metabolic assays
-Rubidium efflux assays as a measure of potassium channel activity (Rubidium acts as a surrogate for cation movement across the cell membrane)
Biogen IdecManufacturing Associate
Mar. 2012 - Apr. 2012RTP, NCLarge Scale Manufacturing
Purification of Monoclonal Antibody Products
Good Manufacturing Practices
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