Job Description
Description:
The Judge Group has a new opportunity for a Senior Laboratory Analyst. This will be for a long term contract going for 12+ months and will be fully onsite in Lexington, MA.
IT Technology Skills & Competencies
• IT Experience deploying and supporting Quality and Manufacturing Systems including Analytical Instruments – Empower, Chromeleon, SOLO VPE, GE Unicorn, Nova Biomedical Bioprofile CDV and Flex2, Roche Cedex, Roche LightCycler 480, FileMaker Pro, Bartender, Charles River EndoScan-V, GE 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, BAS, Historians
• Experience with Computerized Systems Validation (CSV), 21 CFR Part 11 regulations, and Data Integrity compliance And AIQ Analytical Instrument Qualification
• Experience working with ITIL processes in ServiceNow such as Incident Management, Change Management, Problem Management, Asset and Configuration Management (CMDB)
• Familiarity with following tools and processes –
o TrackWise – CAPA, Deviation, Change Control
o Veeva – Document Workflows
o SABA – Training Compliance
• Familiarity with Operational Excellence and/or Continuous Improvement processes
• Knowledge and familiarity of following Tools and technologies
o MS Office 365, MS Visio, MS Project
o Citrix, Windows Desktop, Windows Server, SQL Databases, LDAP, Group Policy, TCP/IP Networks, Server Virtualization, RDP, Backup and Restore
• 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 (required)
• Bachelor's degree in information technology, computer science, engineering, or business administration (preferred)
• Experience in the Pharmaceuticals or Life Sciences industry (preferred)
• Experience consulting or working in a complex, global matrix organization (preferred)
o Knowledge of Lean operational techniques (preferred)
• Work closely with project teams (IT, Business, Validation, and QA) during planning and design phases to ensure appropriate solutions
• Consult during the selection of external service providers
Evaluate proposed IT infrastructure changes to determine potential impacts to systems operations and compliance
Contact: cbeasty@judge.com