Center Technician Quality Assurance
Resume:
Gun Woo (Kevin) An
Biological Engineer
adxl5b@r.postjobfree.com
SKILLS
LANGUAGES
English
Korean
WORK EXPERIENCE
Quality Assurance Associate
Grifols Plasma
April 2022 – February 2023 Athens, GA
o Performed batch record review of equipment and information logged into the central information database (NexLynk).
o Maintained the highest level of quality of the product. o Documented issues and deviations from procedure to maintain compliance of FDA, EMA, COLA, and PPTA.
o Documented Type I, II, and III deviations on Trackwise and any issues that deviated from procedure, then determined the root cause the issue. Upon determining the root cause, a CAPA was developed to ensure compliance and avoidance of similar mistakes.
o Conducted compliance meetings with other members of Quality Assurance and Management, and discussed trends that were observed and possible solutions.
Donor Center Technician / Phlebotomist (Trainer)
Grifols Plasma
August 2021 – March 2022 Athens. GA
o Performed over 2000 venipunctures with an success rate of approximately 97%.
o Performed checks on vital signs and overall wellness of donors to determine donor suitability.
o Trained over 30 employees on phlebotomy, donor registration, and donor screening.
o Maintained compliance through abiding by guidelines set by the FDA, PPTA, COLA, and EMA
Teaching Assistant
University of Georgia
August 2020 – May 2022 Athens, GA
o Taught 400+ students over 8 courses which included Biomechanics, Engineering Physiology, Tissue Engineering, and Foundations of Engineering.
o Provided office hours on a weekly basis to supplement the students’ knowledge from concepts learned from the previous lecture. o Graded all assignments, quizzes, and exams. In addition, all grades were uploaded onto UGAs centralized system for grades (eLearning Commons)
o
EDUCATION
BS in Biological Engineering with an Emphasis in Bioinstrumentation University of Georgia 2019
CERTIFICATIONS
Google: Data Analytics (2023)
Google: Project Management (In
Progress)
Athens, GA
R SQL
Tableau Excel
Trackwise
HOBBIES & INTERESTS
o Cooking
o Golf
o Animals
o Classic Rock
o Reading
o Craft Beer
Word
PowerPoint
Highly motivated biological engineer with excellent written and verbal communication skills. Recently completed the Google Data Analytics certificate and is looking for opportunities to expand my knowledge in data analytics tools such as SQL, Excel, Tableau, and R. Additionally, worked as a Quality Associate to maintain compliance with Federal and International Agency’s guidelines.
Waterfall
Project Management RACI
Project Charter OKRs
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