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**Job Function: **
Quality
**Job Sub Function: **
Quality Control
Job Category:
Professional
All Job Posting Locations:
Incheon, Korea, Republic of
Job Description:
**Job title: **QC Analyst
**Job Type: **Fix-term (Contract)
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 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 (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)
- 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
Other requirements:
Preferred:
- Experience in pharmaceutical industry
- Experience in QC department
- Experience in performing testing and troubleshooting
- Fluency in English
**Required Skills: **
Preferred Skills:
Analytical Reasoning, Business Behavior, Compliance Management, Continuous Improvement, Controls Compliance, Data Analysis, Execution Focus, ISO 9001, Persistence and Tenacity, Quality Control (QC), Quality Control Testing, Quality Standards, Quality Systems Documentation, Report Writing, Sample Testing, Technologically Savvy