Job Description:

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Johnson & Johnson has announced preliminary plans to close the manufacturing facility in Incheon as part of a global supply chain reorganization. The plan remains under review and may evolve as discussions progress. Any potential closure would follow applicable legal requirements, regulatory approvals, and other customary conditions.

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If you accept this role, you would be employed by Janssen Vaccines on a fixed-term basis throughout the transition period, and your employment would be governed by Janssen Vaccines’ processes, programs, policies, and benefit plans. Additional details will be shared by Janssen Vaccines at the appropriate stage.

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필수 직무 & 책임 Essential Job Duties & Responsibilities

General Laboratory Activity

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• Complies with laboratory safety requirements
• Complies with laboratory related regulation and requirements
• Preparation/Revision and review of GMP documents (Test method documents, Lab notes (Worksheet), Procedures)
• Usage and Management of GMP document / Assure that GMP documents are properly maintained and/or archived
• Internal and external audit/inspection Preparation and Response
• Other laboratory Support activity (e.g., housekeeping)

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QC Laboratory Test Activity

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• Perform QC test in compliance with GMP and corporate requirements/Procedures
• Review of analytical data
• Perform Lab investigation when an issue occurred
• Perform data integrity activity according to local regulation and JNJ internal
• Utilizes electronic systems (LIMS, MES, LES, Empower, etc.) for execution and documentation of testing

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QC Laboratory Management

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• Laboratory system administration (LIMS. Empower, etc.)
• Lab equipment management (Qualification (Instrument Decommissioning included), Calibration, Maintenance, etc.)
• Coordinate/Document/Handling non-conformances, corrective actions (CAPAs) and changes (change control management)
• Lab activities for creating a Safe Lab Environment
• Accompany visitors and provide training to visitors
• Manage and Review of GMP data in compliance with GMP and corporate requirements/Procedures
• Keep supervisor informed of task status and issues
• Complete corrective and preventative actions (CAPA) as assigned

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최소 자격요건 Minimum Qualification

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• Minimum bachelor’s degree (in Chemistry, Chemical Engineering, Life Science, Pharmaceutical Engineering, or related fields)
• Understanding of current Good Manufacturing Practices (cGMP) related to the QC laboratory and compendial (USP, EP, JP, etc.) requirements
• Good Interpersonal communication and Collaboration skills
• Demonstrated ability to organize and prioritize workload

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기타 필수 요건 Other requirements

Preferred:

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• Experience in pharmaceutical industry, QC department (1~4 years of experience required)
• Experience in performing testing and troubleshooting
• Fluency in English

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Please note that this job is a fixed-term employment contract.

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