Onsite role in Lexington, MA; possible remote work at manager’s discretion after fully up to speed
W2 Candidates only
Overall:
- 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 LightCycler 480, FileMaker Pro, Bartender, Charles River EndoScan-V, Client DataPro2, Informait InForm/CC, Lonza WinKQCL, Mettler Toledo LabX, PerkinElmer Asset Genius, Thermo WebAdmin for TruScan 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 ServiceNow such as Incident Management, Change Management, Problem Management, Asset and Configuration Management (CMDB)
- Familiarity with TrackWise (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.
The Fountain Group
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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