Johnson & Johnson is looking to ensure their Janssen US Stability sites remain compliant with corporate and regulatory requirements, maintaining inspection readiness through audits and adherence to regulations.
Requirements
- Knowledge and understanding of current Good Manufacturing Practices (cGMP)
- Basic knowledge of analytical technologies used in a Quality Control Stability Laboratory
- Basic Knowledge of global regulatory and compendial (USP, EP, JP, etc.) requirements
- Ability to participate and lead an individual project with minimal guidance from supervision/management in the training and document management space.
- Proficient with using Microsoft Office applications (Outlook, Excel, Word, and PowerPoint)
- Proficient with Quality Systems for training and document management (e.g., Trackwise, ComplianceWire, SUMMIT, TruVault)
- Ability to write and/or effectively review documents for Good Document Practices (GDP)
Responsibilities
- Maintains inspection readiness system and activities for the site
- Participates in quality audits, inspection activities and responses
- Draft, edit, review and approve department standard operating procedures (SOPs) and work instructions (WIs)
- Provides training for Quality concepts or systems
- Responsible for assuring compliance to all relevant regulatory requirements (e.g., global cGMPs, DEA, EH&S) is monitored and gaps are mitigated
- Coordinates, maintains, tracks, monitors, reports and drives quality metrics
- Monitors non-conformance and commitment data for trends
Other
- Successfully completes regulatory and job training requirements
- Assembles information (i.e., builds charts, graphs, etc.), participates in Site Management Reviews (SMR) and tracks action items to closure
- Escalates issues to management in timely manner and works with management to address and remediate issues
- May occasionally assist the supervisor in establishing priorities
- Ability to influence others successfully
