QC Specialist (5년 이상, Chemical Lab / Micro Lab)

• Introduce the standardized equipment needed to build Quality Control Laboratory of new site and contribute to interpretation of results according to specialized test methods.
• Define User Requirement Specification (URS) of equipment needed to build laboratory, with sufficient understanding of product and testing methods, and conduct qualification to ensure that specialized laboratory equipment.
• Responsible for re-qualification and maintenance for life cycle of lab equipment and ensure to perform standardized procedures such as daily check.
• Carry out analytical method validation and verification based on understanding of test method. Collaborate closely on analytical tech transfer from giving sites and contribute to resolve issues that arise during the implementation.
• Responsible for preparing reagents, standards, and columns required for testing. Perform inventory and storage management to ensure smooth test operation.
• Document validated test methods and other required analytical documents e.g. SOPs, work instruction based on understanding of GMP.
• Contribute to problem solving associated with laboratory work such as OOT/OOS/DEV investigation.
• Ensure that all laboratory operations maintain high level of safety, environmental protection and management and build systems that comply with the cGMP requirements of the relevant quality system.
• Strictly comply with company EHS safety regulations and master skill of safety work and emergency rescue knowledge.
• Take responsibilities in assigned projects as appropriate.
• Actively report quality related events and participate in continuous quality improvement activities.
• Overall performance of daily QC Specialist operations (chemical lab) in the new facility.

• Minimum bachelor's degree in pharmaceutical sciences, life sciences, biology, biotechnology chemistry, analytical chemistry, or a related discipline.
• +5 years in the pharmaceutical, biotechnology or medical device in QC chemical lab(experience in biochemistry lab will add value) LIMS&SAP experience will add value
• Experience in introducing various chemical and biochemical test equipment and tech transfer.
• Fluent in English.
• Team working

• Participate in designing microbiology testing labs for new site, ensuring Quality Control environment that meets regulatory compliance standards.
• Define user requirement specifications for QC equipment based on understanding of products and testing method. Conduct qualification of QC equipment and computerized system validation of QC systems.
• Perform verification and validation of microbiological testing methods and collaborate on technology transfer from giving sites to ensure successful implementation of transferred technologies.
• Ensure product quality based on deep understanding of microbiological testing techniques.
• Responsible for qualification of clean room, and clean utilities, managing scheduling and resources.
• Participate in aseptic process validation, cleaning validation and process validation.
• Establish relevant analytical document (e.g., specifications, methods, logbooks) and local SOPs to comply with company standards.
• Conduct microbiological testing-related education and training to strengthen the capabilities of the QC team.
• Manage and maintain equipment and reagents required for microbiological testing.
• Contribute to problem solving associated with laboratory work such as OOT/OOS/DEV investigation.
• Ensure that all laboratory operations maintain high level of safety, environmental protection and management and build systems that comply with the cGMP requirements of the relevant quality system.
• Take responsibilities in assigned projects as appropriate.

• Minimum bachelor's degree in pharmaceutical sciences, life sciences, biology, microbiology, or a related discipline.
• + 5 years in the pharmaceutical, biotechnology or medical device in QC micro lab.
• Experience in developing and maintaining QC micro systems and SOPs.
• Good communication and collaboration skills with team members.
• Flexibility and adaptability.
• Fluent in English.

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• 서버 안정성을 위해, 인터넷 익스플로러가 아닌 구글크롬, 혹은 마이크로소프트 엣지를 통한 지원 바랍니다.

• 보훈대상자 및 취업보호대상자는 관련법에 의거하여 우대합니다.

• 지원서의 기재사항이 사실과 다른 것으로 확인되거나 Reference from previous employer 상에 채용상의 결격사유가 확인될 경우 합격 또는 채용이 취소될 수 있습니다

• (The company reserves the right to withdraw the offer, it if discovers subsequently that a candidate has given false information in application or has provided false or fraudulent documentation in support of his/her application. The offer is conditional upon satisfactory results of reference checks.)

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