Arena Pharmaceuticals, Inc., a leading San Diego-based biotechnology Company, is seeking a candidate for QA DATA SYSTEMS ADMINISTRATOR.
Arena offers an exciting work environment, competitive salary, excellent benefits package, including 401(k) and stock options. Email responses to: firstname.lastname@example.org or apply online at http://www.arenapharm.com/careers.aspx Please reference Job code: 0344100313.
The successful candidate will coordinate and manage the Electronic Data Systems and Electronic Document Management Systems (EDMS) for Quality Assurance. The position will report to the Director, Quality Assurance and will interact with IT, Regulatory Affairs, Drug Safety and Clinical Operations as well as other departments and manufacturing facilities as necessary.
Essential Duties and Responsibilities:
• Administer regulated data management systems managed or operated by and for Quality Assurance (QA), including but not limited to EDMS, TrackWise, SAP, LIMS, eCTD, Calibration manager, Electronic Laboratory Notebook and OpenText Livelink;
• Train QA users in Arena data management systems, and train Arena staff in QA specific data management systems;
• Configure QA user permissions and workflows as needed within Arena data management systems;
• Project management of QA related computer system projects;
• Manage the QA data management systems;
• Manage the creation, modification, activation and termination of QA system users;
• Process documents for Computer System Validation;
• Support the validation of QA data management systems by executing user acceptance protocols, gathering user requirements and supporting internal and contract validation engineers;
• Provide creative and innovative recommendations and assist in implementation of new document control systems and/or changes to existing document control systems.
BioSpace.com - 16 months ago
Arena Pharmaceuticals, Inc. (Arena) is a clinical-stage biopharmaceutical company focused on discovering, developing and commercializing...