[Janssen Vaccines] Associate Analyst QC, Large Molecule

About Johnson & Johnson

At Johnson & Johnson,?we believe health is everything. Our strength in healthcare innovation empowers us to build a?world where complex diseases are prevented, treated, and cured,?where treatments are smarter and less invasive, and?solutions are personal. Through our expertise in in pharmaceutical, and medical devices and diagnostics markets Janssen and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/.

1. ???: Associate Analyst QC, Large Molecule

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[Responsibilities]

1.General Laboratory Activity

• 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)

2.QC Laboratory Test Activity (Main Tasks)

• 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

3.QC Laboratory Management

• Coordinate/Document/Handling non-conformances, corrective actions (CAPAs) and changes (change control management)
• Improvement of lab practice
• Perform maintenance for lab equipment
• 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

[Requirements]

• Minimum Bachelor's degree (in Chemistry, Chemical Engineering, Life Science, Pharmaceutical Engineering, or related fields)
• Experience in pharmaceutical industry
• Experience in QC department is preferred, but not limited
• Experience in Large Molecule DP testing is preferred, but not limited
• 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
• Knowledge and understanding of current Good Manufacturing Practices (cGMP) 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.

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[For more Johnson & Johnson]

• J&J Linkedin: https://www.linkedin.com/company/johnson-&-johnson/
• J&J Corporate Page: http://www.jobkorea.co.kr/Company/1605233/Info

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www.careers.jnj.com