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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 Experienced Analyst
**Job type: **Fixed-term (Contractor)
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)
- Supervision
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)
- Minimum** 6+ years of work experiences **in QC lab and related to the tasks
- 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, Controls Compliance, Cross-Functional Collaboration, Innovation, ISO 9001, Persistence and Tenacity, Problem Solving, Process Oriented, Quality Auditing, Quality Control (QC), Quality Control Testing, Quality Standards, Quality Systems Documentation, Report Writing, Technologically Savvy