Job Description :
Job Title: TrackWise Developer
Job Location: RTP, NC 27709
Job Duration: 11+ Months Contract
Must have''s: Trackwise (Oracle database, SQL skills), Crystal Reports, Java
Job Description:
Incumbent will be part of a distributed / virtual team providing technical applications support to Biogen Pharmaceutical Operations and Technology personnel (PO&T The ideal candidate will have technical knowledge of TrackWise and at least 5+ years of experience working in a GMP environment. Being an effective communicator, interpersonal skills and a proven customer service background is a must. The goal is to assist the TrackWise technical team and business units during a major upgrade of TrackWise.
Primary Responsibilities
Coordinating with DBA team for database migration and upgrade and installing new web servers.
Coordinating with Testing Center on test script creation and review which includes regression analysis.
Coordinating with the Web Services Developer in identifying existing web services and steps for regression testing.
Coordinating with the Crystal Reports Developer in identifying existing reports and steps for regression testing.
Develop, document and perform the database upgrade steps and installation of web servers (including Coordinator and report servers
Coordinating with current TrackWise Admin staff in the updating of the TrackWise core documentation.
Coordinating with the Training Department and business units for training materials and determining SOP impact.
Coordinating with the Project Manager on project scheduling and providing status updates to meet define project milestones.
Troubleshoot technical issues impacting system performance, system integrations and workflows to reduce outages.
Recommend and execute process improvements and value additions to improve user experience.
Implement configuration changes, Perform technical tasks, software installations, environment refreshes, backups, performance measurement for TrackWise application.
Create/modify crystal reports based on business needs.
Prepare and follow business documentation, work instructions, SOPs and knowledge management information for applications supported.
Document application changes and configuration in appropriate change control and change management systems.
Service follow-up and resolution of escalated service issues and deficiencies as required.
Qualifications
Very Strong Technical hands on knowledge on TrackWise QMS, workflows, its configuration (group categories, user roles, admin queries/triggers, dynamic queries, states, activities, data fields, config forms, etc, Import Utilities, Migrator and Coordinator.
Strong verbal and written communication skills, ability to interact well with a variety of diverse customer groups.
Good organizational skills and an ability to effectively manage multiple and competing initiatives is required.
Strong technical and IT skills are a requirement.
Experience in supporting validated, 21 CFR Part 11 compliant computer systems.
Must have 3+ years of configuration experience with TrackWise application.
Extensive knowledge of troubleshooting techniques, advanced SQL skills, Oracle database structures, application server platforms and operating systems (Windows/Unix
Experience in developing crystal reports.
Experience with other GMP compliance systems (e.g. learning management system, change management systems, ERP) is a plus.
ITIL foundation certification strongly preferred, ITIL process specialty certification(s) desired.
Experience in a biotechnology/pharmaceutical company preferred.
Education
An undergraduate degree in a relevant discipline required. A graduate degree in computer science or operations would be desirable.