Saemena Kim Email & Phone Number

Experienced Quality Control Specialist with 10+ years in microbiological quality assessments, analytical testing, and regulatory compliance. Expertise in product validation, laboratory management, and technical transfers. Skilled in identifying and resolving quality issues, ensuring alignment with GMP/GLP standards.ExperienceQuality Control Microbiology Sub-Team LeadJW Pharmaceutical Corporation | South Korea2018 – 2020• Received the technology transfer for Actemra inj. from Chugai Pharmaceutical (Japan) and applied it to the subsidiary.• Conducted bioassays; validated products and equipment per industry standards.• Managed laboratory operations, equipment calibration, and staff training.• Developed SOPs, maintained and updated GMP/GLP/CAPA documentation, streamlined testing processes.• Improved the quality control system through inspections from various companies and institutions.• Ensuring regulatory compliance and quality control.Microbiology Lab Specialist, Associate ManagerJW Pharmaceutical Corporation | South Korea2013 – 2018• Performed quality control tests (sterile, endotoxin, microbial limit tests) on raw materials, intermediate products, and finished goods. set F-value of product.• Managed reagent, media, and strain inventories; ensured proper documentation of results.• Recorded, analyzed, and interpreted test data to maintain product quality.Microbiology Lab SpecialistJW Life Science | South Korea2011 – 2013• Environmental Monitoring throughout the manufacturing process(microbial contamination, air, surface, water sample).• Performed Microbiology quality control tests (sterile, endotoxin, microbial limit tests) on raw materials, intermediate products, and finished goods. BI test.• Experienced various inspectionsResearch InternDoohan Bio Company | South Korea2010 – 2011• Qualified new raw materials according to USP/EP guidelines.Research AssociateSeverance Hospital, Yonsei University for Ophthalmology | South Korea2009 – 2010• Performed PCR, Western blot, Protein purification, Electrophoresis, Miniprep, Animal test, Primary cell culture from rats, and maintain cell cultures.Skills• Laboratory: Technical transfer, Cell primary culture, bioassay, Lab management, PCR, Protein purification, Western blot, Electrophoresis Microbiology experiments (Diagnosis & Manage strains, Endotoxin test, Sterile test, Microbial Test, BI test, Heat Resistance test, Monitoring, etc.), GMP, SOP, GLP, CAPA documents managing.• Software/Tools: LIMS, QMS, EDMS, SoftMax Pro • Regulatory Knowledge : GMP, GLP, SOP, CAPA

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  Quality Control Manager

  Jw Pharmaceutical Corporation

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  Ajou University(아주대학교)

  Biomedical Sciences, General