Gokarna Karki
Biomedical Engineer | Quality | R&D | Validation | Researcher |
- Role
- Quality Control Analyst at Aldevron
- Location
- Fargo, ND, US
- LinkedIn followers
- 500 followers
Experience
Quality Control Analyst
Sep 2024 — Present · Fargo, ND, US
Conduct routine monitoring of ISO 7 and ISO 8 manufacturing rooms, including surface, air, and particle sampling. Perform DNase, RNase, endotoxin, TOC, conductivity, and water bioburden testing; conduct data analysis, update results in LIMS, and monitor for abnormal trend deviations. Conduct plate reading and microbiological analysis of routine and in-process (IP) environmental monitoring (EM) samples, including identification of recovered microorganisms, trend evaluation, and initiation of Quality Events Review and update EM SOPs and related forms to incorporate process improvements, identify areas requiring revision, and implement continuous improvement initiatives to enhance the efficiency, accuracy, and cost-effectiveness of EM operations. Perform EMPQ activities for modified classified areas, including execution of dynamic and static viable and non-viable sampling, data analysis, and establishment of qualified surface, air, and particle sampling locations; update sampling maps and associated SOPs in compliance with GMP and aseptic processing requirements.
Education
Tribhuvan University
B.E. Electronics and communication, Electrical, Electronics and Communications Engineering
Southern Illinois University, Carbondale
Master's degree, Bioengineering and Biomedical Engineering
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