포지션 상세
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.
• Complies with laboratory related regulation and requirements
• Preparation/Revision and review of GMP/GLP documents (Test method documents, Lab notes (Worksheet), Procedures)
• Usage and Management of GMP document / Assure that GMP/GLP documents are properly maintained and/or archived
• Internal and external audit/inspection Preparation and Response
• Other laboratory Support activity (e.g., housekeeping)
• Perform QC testing in compliance with GMP and corporate requirements/procedures
• Review analytical data and test results
• Conduct and/or support laboratory investigations when issues occur
• Perform data integrity activities in accordance with applicable regulations and J&J requirements
• Utilize electronic systems (e.g., LIMS, MES, LES, Empower) for execution, review, and documentation of laboratory activities
• 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)
• Manage and Review of GMP data in compliance with GMP and corporate requirements/Procedures
• 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
주요업무
• Complies with laboratory safety requirements• Complies with laboratory related regulation and requirements
• Preparation/Revision and review of GMP/GLP documents (Test method documents, Lab notes (Worksheet), Procedures)
• Usage and Management of GMP document / Assure that GMP/GLP documents are properly maintained and/or archived
• Internal and external audit/inspection Preparation and Response
• Other laboratory Support activity (e.g., housekeeping)
• Perform QC testing in compliance with GMP and corporate requirements/procedures
• Review analytical data and test results
• Conduct and/or support laboratory investigations when issues occur
• Perform data integrity activities in accordance with applicable regulations and J&J requirements
• Utilize electronic systems (e.g., LIMS, MES, LES, Empower) for execution, review, and documentation of laboratory activities
• 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)
• Manage and Review of GMP data in compliance with GMP and corporate requirements/Procedures
자격요건
• 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
