QC IT Application Analyst
Apply NowCompany: Katalyst HealthCares and Life Sciences
Location: Lexington, MA 02421
Description:
Responsibilities:
- 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.
- 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.
- Service now, Veeva, Trackwise, Active Directory, firewall rules, My Access, NTFS permissions.
- Applications impacted by upgrades, Ideal 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.
- More than 10 years relevant IT/business experience, analysis, and documentation of business and technical requirements (required).
- Bachelor's degree or equivalent in information technology, computer science, engineering, or business administration.
- Experience in the Pharmaceuticals or Life Sciences industry.
- Knowledge of Lean operational techniques.
- IT Experience deploying and supporting Quality and Manufacturing Systems including Analytical Instruments, 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 following tools and processes - TrackWise - CAPA, Deviation, Change Control Veeva - Document Workflows.
- Familiarity with Operational Excellence and/or Continuous Improvement processes.
- Knowledge and familiarity of 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.