The Quality Systems Analyst Senior supports the implementation and maintenance of electronic Quality Management System (eQMS) for the Northpointe Facility, including training, development of standard operating procedures (SOP) and serving as the site representative for global community of practices teams.
- Administration of electronic Quality Management Systems (eQMS) for the Northpointe facility.
- Develop and maintain SOPs related to the eQMS (such as deviation, CAPA and change control
- Train personnel and provide technical support to users of the eQMS.
- Be the primary contact for outside vendors during research of new systems, installation, modification, training, and development of application software.
- Be the primary contact for IT and Validation groups for eQMS.
- Monitor and respond to application problems using appropriate problem determination tools; track problem occurrence and resolution; identify, diagnose and repair complex problems; take corrective action to prevent or minimize system issues.
- Troubleshoot to resolve system-related problems; coordinate with relevant IT staff and/or third party vendors regarding user support and problem resolution.
- Provide project leadership in planning, design, implementation and support of business applications; ensure interface with existing application, network and operational server environments
- Develop and implement operational standards and procedures for eQMS applications, including those for performance, backup, and security; interface with IT staff for development and monitoring of off-hours and special procedures.
- Perform administrative responsibilities for the eQMS applications.
- Participate in Change Control planning meetings and support change owners in the change process ensuring requirements and implementation strategies are appropriate.
- Prepare site metrics for Quality Management Review related to applicable Quality Systems
- Independently determines and develops approach to solutions related to deviation, CAPA and change control programs.
- Support Annual Product Review related to deviation, CAPA and change control.
- Provide technical expertise both internally and externally for quality systems related projects.
An ongoing commitment to conducting business according to the highest legal and ethical standards, and to continually pursue excellence in the development and delivery of all of our products and services. This includes:
- Respecting the laws and operating within the applicable regulations of the places in which we conduct business, as well as our own Company policies and procedures.
- Being honest and treating people with respect and courtesy.
- Constantly striving to make Genzyme a great place to work, and a company respected for the quality of its people and products.
- Acting as role models for our fellow employees by acting responsibly, fairly, and honestly in our dealings and exercising sound judgment in performing our jobs.
- Typically 5-8years related experience in cGMP/FDA regulated industry.
- Detailed knowledge and experience in Quality Management Systems
- Individual should have attention to detail and excellent written & oral communications skills
- Experience implementation and administration of ectronic systems for the management of deviations, CAPAs and change control
- Project Management experience
- Proficiency in Microsoft PowerPoint, Word and Excel