Job Description:

Location: Lexington, MA

Description:

Overview: The QC IT Application Analyst collaborates with business and IT teams to support MA Biologics Operations Site Functions, including Quality, Validation, and Product Development. This role requires managing tasks with limited oversight.



Key Responsibilities:



• Upgrade projects from Windows 7 to Windows 10.


• Oversee vendor-provided solutions.


• Handle ad-hoc technical requests from internal and external partners.


• Collaborate with team members for decisions and clarifications.


• Manage multiple projects and deliverables, splitting billing time as needed.


• Perform design testing of applications and author SDLC documents (SDCS, URS, FRA, Admin SOP, IQ, IOQ, ATR, Application Data Flow diagrams, etc.).


• Possess GxP experience with lab equipment.



Recommended Experience:



• ServiceNow, Veeva, TrackWise, Active Directory, firewall rules, My Access, NTFS permissions.


• Excellent written and verbal communication skills.



Applications Impacted by Upgrades: Ideal candidates should have experience implementing or upgrading the following applications (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 & Experience:



• Over 5 years of relevant IT/business experience, including 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).



IT Technology Skills & Competencies:



• 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 environments).


• Familiarity with Automation systems (SCADAs, PLCs, DCS, BAS, Historians).


• Experience with Computerized Systems Validation (CSV), 21 CFR Part 11 regulations, and Data Integrity compliance.


• Experience with ITIL processes in ServiceNow (Incident Management, Change Management, Problem Management, Asset and Configuration Management - CMDB).


• Familiarity with tools and processes:


o TrackWise (CAPA, Deviation, Change Control)


o Veeva (Document Workflows)


• Familiarity with Operational Excellence and/or Continuous Improvement processes.


• Knowledge of the 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


o Architectures (2 Tier, 3 Tier, On-premise, Cloud)

Contact: cbeasty@judge.com


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