QC Specialist

Your Role:

• Participate in routine Microbial testing of raw materials and finished products using various testing techniques. (i.e. Microbial limit, Sterility, Endotoxin, Bioburden, Cell based growth promotion test, Cytotoxicity, MTT, Cell-line management, AVA, Mycoplasma, others etc.)
• HVAC Environmental Monitoring and Water, Gas quality manage (EM, PW/WFI/PS, N₂/CA)
• 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.
• Working in QC lab according to ISO 9001, 45001, 14001, EXCiPACT and EHS guideline in Korea.
• 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.
• 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.
• Proper maintenance and troubleshooting of measurement system
• Support tech transfer of products from giving sites and ensure equivalent quality.
• Revise, review and write new SOP’s or update existing procedures
• Perform and participate in out-of-specification and deviation investigations
• Collaborate with global site SMEs on relevant subjects.

Who you are:

• Minimum bachelor's degree in pharmaceutical sciences, life sciences, biology, microbiology, or a related discipline
• 5+ years QC in the pharmaceutical, biotechnology or medical device
• Additional experience in animal cell management (e.g., CHO, BHK, MDBK) or GMP laboratory experience in animal cell–related testing is preferred
• Good global communication skills and a collaborative global team mindset.
• Good decision-making and problem-solving capability.
• Experience in managing microbiological tests
• Fluent in English

*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.