Job Description: QC IT Systems Lab Support
IT Lab Systems Requirements
• Can easily decipher from a lab system where data objects are stored and how its protected (main data, audit trail, methods, reports, templates, etc.). As a result, being able to develop data flow diagrams that also tie to how a system will be used.
• Work with infrastructure teams to assure proper backups of Lab systems are setup.
• Use various IT tools such as windows NTFS permissions, active directory, group policies, etc, to implement and deploy systems data integrity risks minimized.
• Deploy workstations and install applications on both client and servers as needed for application.
• Support ongoing DI related initiatives, Remediation Plans and other projects.
• Perform and help with periodic activities like User account reviews, Audit trail reviews and Admin audit trail reviews as system owner
• Follow Computerized Systems Validation (CSV) process and Software Development LifeCycle (SDLC) methodology to build out and qualify the application.
• As application SME, work with infrastructure teams to request server architecture, and perform installation of application.
• Directly responsible for deployment, as well as authoring IT validation documents such as System Design and Configuration Specifications (SDCS’s) and Installation Qualifications (IQ), Backup
• Configuration and Restore Protocols, and System Administration Procedures.
• Assist with and provide input as SME and System Owner for other documents in validation process, such as User and/or Functional Requirements, Risk Assessments, Operational Qualification related to software functions, etc.
• As incidents come in, work on troubleshooting and resolving issues for end users for site applications.
• Contacting vendors as needed for troubleshooting and resolving issues.
• Creation/Modification of user accounts in applications as needed following administration procedures
Education and Experience
Essential: Bachelors Degree in Computer Science or related field with 3 years or more experience
Desired: Bachelors Degree and Masters Degree in Computer Science or related field with 4 years or more experience
Key Skills, Abilities, and Competencies
• Describe critical skill and abilities needed to successfully perform the job, which should be representative of the knowledge, skills, and abilities required, Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
• Developing and executing CSV/AIQ deliverables according to regulatory authorities for GxP computer systems to support commercial and development activities. IT Technology Skills & Competencies:
• IT Experience deploying and supporting Quality Systems including Analytical Instruments – Empower, Chromeleon, SOLO VPE, Roche Cedex, Roche LightCycler 480, GE DataPr02, Lonza WinKQCL, Metter Toledo LabX, Thermo WebAdmin for TruScan RM Analyzer, and various Laboratory desktop applications used in GIP environment
• Experience working with ITIL processes in ServiceNow such as Incident Management, Change Management, Problem Management, Asset and Configuration Management (CMDB)
• Familiarity with Operational Excellence and/or Continuous Improvement processes
• Knowledge and familiarity of following Tools and technologies: MSOffice 365, MS Visio, MS Project, Citrix, Windows Desktop, Windows Server, SQL Databases, LDAP, Group Policy, TCP/IP
• Networks, Server Vitualization, RDP, Backup and Restore Complexity and Problem Solving
Assess change controls for impact to validated computer systems and participate in corrective and preventive actions (CAPA) and other Quality Management System (QMS) activities. Internal and External Contacts
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