QC IT Application Analyst

USDM Life Sciences is a premier consulting company with 20+ years of experience assisting heavily regulated biotech, medical device, and pharmaceutical companies with their GxP technologies to accelerate growth. Our deep domain knowledge and technology expertise in life sciences business processes are what set us apart. From strategy to implementation and adoption, we have delivered thousands of GxP projects globally.

As part of the USDM team, you have the opportunity to work with cutting‑edge technologies through our many partnerships with companies like Microsoft, Google, Oracle, Docu Sign, Box, and many more. From molecule to market, you will help connect technology, people, and data in new ways to generate real‑time insights to improve business outcomes for USDM’s clients. Are you ready to make an impact and drive real digital transformation in life sciences?

Founded in Santa Barbara in 1999, USDM has grown to a progressive, global company with 300+ remote employees and offices throughout the US, Canada, and Germany.

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)

• 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 scope of work includes, but is not limited to the following:
• Project upgrades from Win7‑Win
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• 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.

• Performs other related duties and assignments as required

• Systems & Tools:
  Experience with Veeva, Track Wise, and Service Now is preferred. The team operates in a Windows environment, and strong proficiency in Word and Excel is essential for document revisions, updates, and design work.
• Experience with Computerized Systems Validation (CSV), 21 CFR Part 11 regulations, and Data Integrity compliance
• Experience working with ITIL processes in Service Now such as Incident Management, Change Management, Problem Management, Asset and Configuration Management (CMDB)
• Familiarity with following tools and processes – Track Wise – 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

Bachelor’s degree in Computer Science or Information Systems or related field if preferred.

The working conditions described here are representative of those that must be met by an employee to successfully perform the essential responsibilities and functions of the job and are not meant to be all inclusive. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential responsibilities and functions of the job.

Unless reasonable accommodations can be made, while performing this job the staff member shall:

• Prolonged periods of sitting or standing at a desk and working on a computer in an environmentally controlled home office environment.
• Operate other office…