[Janssen Vaccines] Associate Analyst QC

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 Innovative Medicine 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

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About Innovative Medicine

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at https://www.jnj.com/innovative-medicine

We are searching for the best talent for Associate Analyst QC to be in Incheon.

You will be responsible for:

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)

QC Laboratory Test Activity

• 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

QC Laboratory Management

• Laboratory system administration (LIMS. Empower, etc.)
• Lab equipment management (Qualification, Calibration, Maintenance, etc.)
• Coordinate/Document/Handling non-conformances, corrective actions (CAPAs) and changes (change control management)
• Improvement of lab practice
• 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

Qualifications / 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.
• 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)

Legal Entity

Janssen Vaccines

Job Type

Fixed Term (1 year)

Application Documents

Free-form resume AND cover letter is required (in Korean or English).

Application Deadline

Open until the position is filled.

Notes

• Preference will be given to individuals subject to national veterans’ benefits and persons with disabilities upon submission of relevant documents as per applicable laws.
• Only candidates who pass the resume screening will be notified individually. However, notifications may be delayed due to company circumstances.
• If any false information is found in the application documents, the hiring may be canceled even after the offer is confirmed, and future applications may be restricted.
• Submitted documents will not be returned and will be deleted upon request.