GXP Systems, Contractor
REMOTE, MN 00000 US
*Depending on experience
The Analyst of IT GxP Systems Contract provides direct support to business stakeholders for GxP systems by creating and implementing innovative, relevant principles and technical solutions to support initiatives and ongoing activities. The position will be supervised by IT Business Partner for GxP systems.
ESSENTIAL FUNCTIONS AND RESPONSIBILITIES:
These may include but are not limited to:
· Technical support for Veeva, Compliance Wire, Argus and Tracelink releases
· Technical support for DocuSign GxP
· Technical support for migration of Regulatory documents from various non-GxP systems into Veeva Submissions Vault
· Ensure compliance with all system and process changes to support GxP activities.
· Team member on various business funded IT projects. Work with and support business members of the team
· Computer System Validation activities
ADDITIONAL FUNCTIONS AND RESPONSIBILITIES:
· Other duties as assigned.
EDUCATION, EXPERIENCE, KNOWLEDGE, SKILLS AND ABILITIES:
· Minimum of a Bachelor’s degree preferred or equivalent with at least 6 years’ technical experience (an equivalent combination of experience and education may be considered)
· Previous experience in a Business System Analyst role
· Strong GxP Systems Testing and IT Implementation experience.
· Demonstrated Project Management experience.
TECHNICAL KNOWLEDGE REQUIRED:
Equipment: PC, scanners, facsimile machine, voice mail and e-mail systems, and common office machines, or ability to be trained. Knowledge of other equipment required:
Software Knowledge: Windows, MS Office (Outlook, Word, Excel, PowerPoint). Knowledge of other software preferred: Veeva Vault (QualityDocs, QMS, RIM, and Submissions), TraceLink, and Argus. Additionally, knowledge of Smartsheet, MS Project, Visio, SharePoint and Teams are a plus.
INTERNAL AND EXTERNAL RELATIONSHIPS:
· Regulatory Affairs
· Regulatory Operation
· Supply Chain
· Veeva Managed Services
*CO/NYC candidates might not be considered
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