ONSITE : QC Lab Systems Consultant

• We are looking for a candidate who can support QCIT operations in a GMP environment.
• Will be developing and executing periodic validation activities (backup and restore testing, user access reviews, and audit trail reviews)
• Front-line client support and triage (initial assessment and coordination of repair activities when systems are down)
• Supporting GxP workstation patching activities
• Supporting decommissioning activities (for example, final backups and account deactivations)

• The QC IT Application Analyst collaborates with the business and IT teams to provide project support for MA Biologics Operations Site Functions – Quality, Validation and Product Development.
• The scope of work includes, but is not limited to the following:
  Project upgrades from win 7- win 10, Provide oversight of vendor-provided solutions, Handle ad-hoc technical requests from both internal and external partners in accordance with projects that are assigned.
• Work with other Direct team members for descions, and clariffications as needed Must be able to juggle multiple projects and deliverables, and split billing time between projects where needed.
• Experience with performing design testing of application to help author SDLC documents, including SDCS, URS, FRA, Admin Sop, IQ, IOQ, ATR, Application Data Flow diagrams, etc.
• Must poses GXP experience with lab equipment.

• More than 5 years relevant IT/business experience, analysis, and documentation of business and technical requirements (required)
• Experience with software application implementations in GxP environment
• IT Experience deploying and supporting Quality and Manufacturing Systems including Analytical Instruments – Empower, Chromeleon, SOLO VPE, Client Unicorn, Nova Biomedical Bioprofile CDV and Flex2, Roche Cedex, Roche Light Cycler 480, File Maker Pro, Bartender, Charles River Endo Scan-V, Client DataPro2, Informait InForm/CC, Lonza WinKQCL, Mettler Toledo LabX, Perkin Elmer Asset Genius, Thermo Web Admin for Tru Scan RM Analyzer, and various Laboratory desktop applications used in GxP environment
• Familiarity with Automation systems such as SCADAs, PLCs, DCS, Client, Historians
• Experience with Computerized Systems Validation (CSV), 21 CFR Part 11 regulations, and Data Integrity compliance
• Experience working with ITIL processes in Service Now such as Incident Management, Change Management, Problem Management, Asset and Configuration Management (CMDB)
• Familiarity with Track Wise (CAPA, Deviation, Change Control) and Veeva for Document Workflows
• Citrix, Windows Desktop, Windows Server, SQL Databases, LDAP, Group Policy, TCP/IP Networks, Server Virtualization, RDP, Backup and Restore
• Architectures – 2 Tier, 3 Tier, On-premise, Cloud
• Bachelor's degree or equivalent in information technology, computer science, engineering, or business administration
• Experience in the Pharmaceuticals or Life Sciences industry

Who We Are:
The Fountain Group is a nationwide staffing firm with over 80 Fortune 100-500 clients. Since 2001, TFG has maintained a consistent standard of excellence, and our work is broadly recognized every year through numerous industry performance awards.
Our success is a team effort.
Browse our website below for additional information on our company.

3407 W Martin Luther King Jr. Dr. Tampa, FL 33607
“We work in Life Sciences, Clinical, Engineering, IT, and more. Above all, we specialize in people.”

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