Quality Systems Analyst
Kenvue is a company dedicated to everyday care, built on a century of heritage and scientific expertise. They are seeking a Quality Systems Analyst to execute Document Management, Retention, and Learning Management activities in support of ongoing projects, ensuring compliance with GMP documentation and training requirements.
Responsibilities
- Perform Learning Management System (LMS) transactions including user, item and curricula management, report generation and maintenance of content and completions
- Monitor system through reporting functions to drive completion of outstanding items
- Perform document control activities to ensure GMP documents (controlled documents, logbooks) are managed as required by SOP and regulatory requirements
- Perform operational activities, including document issuance, reconciliation, review and processing in the document management system
- Provide support for the development of document templates, technical editing and formatting as needed
- Monitor system/workflow documentation and drive completion of tasks/outstanding items and ensure compliance
- Ensure adherence to the corporate Records Retention Program and maintain site Records Retention Schedules
- Execute local and corporate SOPs to ensure chain of custody and traceability of all GMP records
- Support stakeholders by performing database searches, file retrieval, scanning & copying
- Serve as an administrator in the records management system which includes entering records, querying the system, filing and reporting metrics
- Support and/or perform system validation/migration activities
- Monitor functionality and communication between systems and related applications
Skills
- Associate's degree or equivalent work experience
- 0-2 years of experience in a pharmaceutical cGMP/manufacturing environment
- Proficiency with MS Office, including Word, Excel and PowerPoint, Adobe, SharePoint and ability to learn new systems
Benefits
- Competitive Benefit Package
- Paid Company Holidays
- Paid Vacation
- Volunteer Time
- Learning & Development Opportunities
- Kenvuer Impact Networks
Company Overview