Humera - Administrative and Professional Staffing

Data Analyst II

Location
Irvine, CA, USA
Salary
Contact For Rate
Posted
Jan 01, 1900
Closes
Feb 23, 2017
Job Type
Employee
Employment Status
Full Time
Humera is currently seeking a Data Analyst II for our client in Irvine, CA. Our client is a world leader in medical device technology. The person in this position will provide support for the Global Trade Services (GTS) application in SAP including daily coverage, extended coverage during quarter end weeks, and mandatory year end shutdown. They will also serve in a back-up role for Unique Device Identifier (UDI) Coordinator, RA Data Analyst, and RA Data Verifier. They will compile, organize, file, retrieve, research and maintain department documents, submissions, logs and records in both hard copy and electronic formats. This position is an expert on general records management and archiving strategies.
Duties:
  • GTS / SAP Activities - Function as back-up and a local expert for all SAP/GTS issues, processes and team support. This will include managing any blocked order issues and conducting any needed investigations or assessments to keep the product distribution active. Participate on all SAP/GTS business and corporate teams as assigned. Provide guidance and problem solving assistance in SAP/GTS related issues.
    • Supporting GTS for Neurovascular Products
    • Quarter End/Year End Extended Coverage
    • Updating GTS blocked order log as necessary
    • Collecting and reporting GTS metrics
    • Contribute to maintenance of Regulatory Information
  • UDI Coordinator / RA Data Analyst / RA Data Verifier ? Understand the responsibilities associated with the three roles and provide back-up support as needed.
    • Provide back-up to the UDI Coordinator / RA Data Analyst / RA Data Verifier
    • Understand and contribute to the development of the processes and procedures related to the UDI coordinator role / RA Data Analyst / RA Data Verifier
    • Become familiar with the UDI RA attributes required for UDI submissions
    • Support process development for UDI objectives and align current procedures as applicable
  • Work within a variety of systems, Document Management System, SAP/GTS, UDI RA Portal, and Regulatory database for managing changes and submissions
  • Responsible for Neurovascular blocked orders as assigned during normal business hours
  • Serve as a team member of the UDI team
  • Support the maintenance of relevant SOPs and associated training
  • Lead or participate on special projects or teams as needed

Requirements:
  • Bachelor degree
  • High attention to detail, highly skilled in task management, task oriented
  • Records and Data Management
  • Microsoft applications, which includes working with templates, and editing and formatting complex documents
  • Competency with various software packages: (Word, PowerPoint, Visio, Excel, Access, Internet, HTML code)
  • SAP experience
Required Skill Sets
  • (Bulleted Required Skill Sets)
  • (Bulleted Required Skill Sets)
  • (Bulleted Required Skill Sets)
  • (Bulleted Required Skill Sets)
Desired Skill Sets
  • Regulatory, Clinical, or Quality experience at a medical device company
  • Working knowledge and/or experience working in SAP or other related system
  • Experience with Agile, Insight or other document management systems used in the medical device/pharmaceutical industry
  • Advanced knowledge level of Microsoft applications, which includes creating templates, editing and formatting complex documents in Word, PowerPoint, Visio, Excel, and Access
  • Experience with Internet/Intranet technology and interactive software applications
  • Flexible with priorities and responsibilities
  • Effective organizational skills and attention to detail
  • Strong work ethic
  • Works well under pressure in a dynamic environment
  • General knowledge of industry practices, techniques and standards

Schedule:
  • Monday - Friday, 7 am - 4pm OR 9 am - 6pm