QC IT Application Analyst -#26-25264

• 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 QC IT Application Analyst manages their work with limited oversight.
• 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).

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.
• Work with other Direct team members for decisions, and clarifications 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.

• 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).
• Experience in the Pharmaceuticals or Life Sciences industry (preferred).
• Experience consulting or working in a complex, global matrix organization (preferred).

Skillsets:

• Service now, Veeva, Trackwise, Active Directory, firewall rules, My Access, NTFS permissions.
• Excellent written and verbal communication.
• Applications impacted by upgrades, Ideal candidate should have previous experience implementing, and or upgrading. Other application experience can be considered.
• IT Technology Skills & Competencies.
• IT Experience deploying and supporting Quality and Manufacturing Systems including Analytical Instruments.
• 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-premise, Cloud.

Education:

• Bachelor’s degree or equivalent in information technology, computer science, engineering, or business administration.