Analyst Quality Control

Job description

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 jnj.com. As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit. Job Function: Quality Job Sub Function: Quality Control Job Category: Professional All Job Posting Locations: Incheon, Korea, Republic of Job Description: [신입가능, 경력선호] 업무명 (Position title): QC Analyst 필수 직무 & 책임 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 최소 자격요건 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 기타 필수 요건 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