QC IT Application Analyst at USDM Life Sciences

About USDM

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 sets 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, DocuSign, 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.

Nature and Scope of Job

USDM Life Sciences is seeking an experienced  QC IT Application Analyst who will collaborate with the business and IT teams to provide project support for Quality, Validation and Product Development.

Primary 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 descions, and clariffications 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 poses GXP experience with lab equipment.

Additional Responsibilities

• Other duties as assigned.

Qualifications

• IT Experience deploying and supporting Quality and Manufacturing Systems including Analytical Instruments.
• Familiarity with Automation systems such as SCADAs, PLCs, DCS, BAS, 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
• 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.
• 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).

Education & Certifications

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

Working Conditions

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 productivity machinery, such as a calculator, scanner, or printer.
• Frequently communicate with stakeholders via telephone, email, or instant message. Must be able to exchange accurate information in these situations.
• Travel to client site for onsite work as needed.
• Must be able to lift, push, pull and carry up to 30 lbs.
• In general, the position requires a combination of sedentary work and walking around observing conditions in the facility.
• Must be able to work in controlled environments requiring special gowning. Will potentially be required to follow gowning requirements and wear protective clothing over the head, face, hands, feet and body.
• No make-up, jewelry, contact lenses, nail polish or artificial fingernails, or any oral food, tabaco, candy etc. may be used in the QC / Manufacturing environment.
• During onboarding and training osite requirement will be 5 days per week. Afterwards minimum 3-4 days a week onsite is required.
• Must be able to work overtime as required.
• May be required to work in a confined area.

Equal Opportunity Statement

USDM Life Sciences is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran. 

Disclaimer

This job description is intended to describe the general nature and the level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. USDM Life Sciences reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.