Johnson & Johnson Santa Ana , CA 92701
Johnson and Johnson Family of Companies is recruiting for a Quality System Specialist, Document Management System, to be located in Santa Ana, CA, to support our Johnson and Johnson Vision business.
Johnson & Johnson Vision is committed to improving and restoring sight for patients worldwide. Since debuting the world's first disposable soft contact lens in 1987, it has been helping patients see better through their world-leading ACUVUE Brand Contact Lenses. In 2017, J&J expanded into cataract surgery, laser refractive surgery (LASIK) and consumer eye health and now serves more than 60 million patients a day across 103 countries with its eye health portfolio. Thriving on a diverse company culture, celebrating the uniqueness of our employees, and committed to inclusion. Proud to be an equal opportunity employer.
You, the Quality System Specialist, Document Management System will develop, recommend and implement Agile system changes and manage the processes to ensure effective compliance to JJSV and external regulations. Manage Agile user training for level 1-4, as defined by business. Serve as the technical system expert for the global product lifecycle management and electronic document management control system, which functions as the system for the approval, release and maintenance of regulated documentation for products and processes. Responsible for monitoring system data integrity and compliance with SAP interface. Functions as Q&C root cause analyst and problem-solving subject matter expert. Provides first line of support to business to troubleshoot system issues and appropriately escalates when intervention is required to ensure global access and use of the business-critical system.
Major Duties include but are not limited to:
Evaluate system issues and procedural compliance. Determine appropriate escalation process as required.
Collaborate with IT to ensure business requirements and needs are met by the Agile System.
Provide Agile user training and continued user support.
Engage with external resources to develop, execute, and complete test scenarios. Write, review, and approve SOPs, test protocols, validations, and reports for Agile system upgrades.
Manage system interface between Agile, SCMNet, LMS ComplianceWire and SAP to provide SME input to resolve issues that may occur.
Own, Investigate, resolve, and implement Agile System CAPA and Non-Conformances
Demonstrate strong organizational, communication, and collaboration skills
Works well in a team-oriented and cross-functional environment
Ability to work with cross functional areas (both internal and Global) as required
Ability to handle multiple tasks and operate in a fast-paced environment.
Experience in writing procedures (i.e. Standard Operating Procedures, test protocols, reports, etc.)
Practical experience with GMP documentation and writing skills in FDA regulated environment
Hands-on knowledge of computer applications including use of the Internet and Microsoft Software applications (Word, Excel, PowerPoint, and Project).
Experience with GxP Quality Systems, including but not limited to investigations, qualifications, validations, CAPA, and NC
Strong working relationship with internal and external customers
Bachelor's degree in a business related or scientific field is required, a technical degree (IT or engineering) is preferred
Minimum of 4 years working experience in highly regulated environment is required.
Experience in the Medical Device or Pharmaceutical etc. industry is preferred.
Basic computer skills (i.e. Word, Excel, Visio, MS Project, PowerPoint) required.
Document management system in a highly regulated environment (AGILE) is required.
Agile PLM System or other electronic change control systems is required.
Experience with compliance wire or other training systems is an asset.
Troubleshooting/problem solving experience is required.
SAP and Skype experience is preferred.
Experience in writing procedures (i.e. Standard Operating Procedures, test protocols, reports, etc.) is required.
Experience with GxP Quality Systems, including but not limited to investigations, qualifications, validations, CAPA, and NC is also required.
Do you strive to join an outstanding team that is dynamic and ever-changing? Is career growth and opportunity appealing to you? Apply to this opportunity today.
Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
United States-California-Santa Ana
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