QC Specialist

<p style="text-align: justify;"> </p><p style="text-align: justify;"><span style="font-size: 18.0px;"><span style="font-family: Verdana, Geneva, sans-serif;"><strong>Your Role:</strong></span></span></p><p style="text-align: justify;"> </p><ul><li>Participate in routine Microbial testing of raw materials and finished products using various testing techniques. (i.e. <strong>Microbial limit, Sterility, Endotoxin, Bioburden, Cell based growth promotion test, Cytotoxicity, MTT, Cell-line management, AVA, Mycoplasma, </strong>others etc.)</li><li>HVAC Environmental Monitoring and Water, Gas quality manage (EM, PW/WFI/PS, N₂/CA)</li><li>Establish QC systems, procedures, and other required analytical documents e.g. specifications, methods, logbooks in the new facility to ensure that Micro-lab operations comply with company standards and customer expectations.</li><li>Working in QC lab according to ISO 9001, 45001, 14001, EXCiPACT and EHS guideline in Korea.</li><li>Participate in qualification of QC equipment, clean room, and clean utilities; analytical method validation, computerized system validation of QC systems. Support cleaning validation and process validation. </li><li>Closely work with project team to design and establish QC labs in the new facility.

Ensure operational readiness of QC labs to support project qualification, validation activities.</li><li>Proper maintenance and troubleshooting of measurement system</li><li>Support tech transfer of products from giving sites and ensure equivalent quality.</li><li>Revise, review and write new SOP’s or update existing procedures</li><li>Perform and participate in out-of-specification and deviation investigations</li><li>Collaborate with global site SMEs on relevant subjects.</li></ul><p style="text-align: justify;"> </p><p style="text-align: justify;"><span style="font-size: 18.0px;"><span style="font-family: Verdana, Geneva, sans-serif;"><strong>Who you are:</strong></span></span></p><p style="text-align: justify;"> </p><ul type="disc"><li>Minimum bachelor's degree in pharmaceutical sciences, life sciences, biology, microbiology, or a related discipline</li><li>5+ years QC in the pharmaceutical, biotechnology or medical device</li><li>Additional experience in animal cell management (e.g., CHO, BHK, MDBK) or GMP laboratory experience in animal cell–related testing is preferred</li><li>Good global communication skills and a collaborative global team mindset.</li><li>Good decision-making and problem-solving capability.</li><li>Experience in managing microbiological tests</li><li>Fluent in English</li></ul><p> </p><p> </p><p><em><strong>*내부 전보 확정 시 법인 이동이 필요한 경우, 퇴직급여 정산 또는 이전 절차 및 각종 사내대출 상환 절차가 필요할 수 있습니다. 내부 지원 시 해당 사항을 숙지하고 지원한 것으로 간주합니다.</strong></em></p>