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USA - Technical Consultant

Sunrise Systems Inc
  • 🇺🇸 United States
  • On-site
  • 1 day ago
  • GMP
  • triage
  • GxP
  • Windows
  • ServiceNow
  • Veeva
  • Active Directory
  • PCR
  • Lean
  • PLC
  • DCS
  • ITIL
  • Change Management
  • Configuration Management
  • CAPA
  • MS Office
  • Visio
  • MS Project
  • Citrix
  • Windows Server
  • SQL
  • LDAP
  • Group Policy
  • TCP/IP
1 day ago
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Job Title: QC IT Application Analyst (JR)
ID: 26-05005
Location: Lexington, MA 02421
Duration: 12-month contract with potential to extend
Position Type: Onsite

NOTE: During onboarding and training, the onsite requirement will be 5 days per week.
Afterwards, a minimum of 3-4 days a week onsite is required

Overall:
We are looking for a candidate who can support QCIT operations in a GMP environment, including:
  • 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)
Job Description:
  • The QC IT Application Analyst collaborates with the business and IT teams to provide support for MA Biologics Operations Site Functions – Quality, Validation and Product Development.
  • The QC IT Application Analyst manages their work with limited oversight.
  • The scope of work includes, but is not limited to the following:
  • Project upgrades from Windows 7 to Windows 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 possess GXP experience with lab equipment.
Recommended Experience
  • ServiceNow, Veeva, Trackwise, Active Directory, firewall rules, My Access,
  • NTFS permissions. Excellent written and verbal communication.
  • Applications impacted by upgrades, Idele candidate should have previous experience implementing and/or upgrading. Other application experience can be considered.
  • Vaya Raman
  • 7500 Fast PCR
  • Hiac Particle Counters
  • Maldi-tof
  • Vi-Cell Cell counter
  • Antaris II
  • Waters Andrew + Alliance
Education and Experience Requirements
  • More than 5 years of relevant IT/business experience, analysis, and documentation
  • of business and technical requirements (required)
  • Experience with software application implementations in a GxP environment
  • (required)
  • Bachelor's degree or equivalent in information technology, computer science, engineering, or business administration
  • Experience in the Pharmaceuticals or Life Sciences industry (preferred)
  • Experience consulting or working in a complex, global matrix organization
  • (preferred)
  • Knowledge of Lean operational techniques (preferred)
Key Skills, Abilities, and Competencies
IT Technology Skills & Competencies
  • 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, clients, 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 the following tools and processes –
  • TrackWise – CAPA, Deviation, Change Control
  • Veeva – Document Workflows
  • Familiarity with Operational Excellence and/or Continuous Improvement processes
  • Knowledge and familiarity with the following Tools and technologies
  • MS Office 365, MS Visio, MS Project
  • 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-premises, Cloud
Contact:
Sunny Rajput | sunny.r@sunrisesys.com | URL: www.sunrisesys.com

USA - Technical Consultant · Sunrise Systems Inc

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