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Job Description:

1.Company: Janssen Vaccines

2. Location: Incheon, Songdo
3. Job type: Fixed-term

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.
 
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. 

Essential Job Duties & Responsibilities:

General Laboratory Activity

• Complies with laboratory safety requirements

• Complies with laboratory related regulation and requirements

• Preparation/Revision and review of GMP/GLP documents (Test method documents, Lab notes (Worksheet), Procedures)

• Usage and Management of GMP document / Assure that GMP/GLP documents are properly maintained and/or archived

• Internal and external audit/inspection Preparation and Response

• Other laboratory Support activity (e.g., housekeeping)

(The responsibilities listed below may be assigned based on business needs, organizational priorities, and the individual's qualifications and competencies.)

QC Laboratory Test Activity

• Perform QC testing in compliance with GMP and corporate requirements/procedures.
• Review analytical data and test results.
• Conduct and/or support laboratory investigations when issues occur.
• Perform data integrity activities in accordance with applicable regulations and J&J requirements.
• Utilize electronic systems (e.g., LIMS, MES, LES, Empower) for execution, review, and documentation of laboratory activities.

QC Laboratory Management

• 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

Minimum Qualification

• Minimum Bachelor's degree (in Chemistry, Chemical Engineering, Life Science, Pharmaceutical Engineering, or related fields
• Knowledge and understanding of current Good Manufacturing Practices (cGMP) or GLP related to the QC laboratory is preferred.  Basic knowledge of compendial (USP, EP, JP, etc.) requirements pertaining to their functional area of QC is helpful
• Fluency in written English and conversational spoken English is preferred.
• Interpersonal communication skills, persuasiveness and an active desire to work together with colleagues and external parties

• Demonstrated ability to organize and prioritize workload

• Good knowledge in the application of Microsoft Office programs. (Outlook, Excel, Word, and PowerPoint)

Preferred Qualification

• At least 3 years of experience
• Experience in pharmaceutical industry
• Experience in QC department is preferred.
• Skilled in performing basic and some advanced testing within the functional laboratory is preferred
• Experience in performing independent troubleshooting & basic root cause analysis skills are preferred

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