Quality Information Systems Analyst

Location
Bothell, WA, United States
Posted
Jul 23, 2018
Ref
21-oVhx7fwA
Hotbed
BioForest
Required Education
Other
Position Type
Full time
Summary:

This position is responsible for supporting the Quality department by ensuring that systems are operational and GMP compliant where required. Management activities of systems may include administrative tasks, maintaining system security, end user training and issue identification and trouble shooting. May provide other technical consulting support for the Quality Information Systems department.

Responsibilities:
  • Responsible for administration of on-premise and hosted software solutions. Manage changes to systems and interact with Quality personnel to improve process and troubleshoot issues within the systems
  • Ensure software solutions meet service level agreements with end users both internal and external
  • Ensure software solutions are inspection ready
  • Assist with creating system validation documents including authoring technical requirements, report specifications
  • Perform validation testing
  • Perform user training as needed
  • Assist in creating/maintaining ECMS department sites on SharePoint
  • Develop and maintain SOPs and ensure documents reflect current practices and are consistent across documents
  • Serve as liaison with IT


Qualifications:
  • This position requires an individual with previous experience in the biotech/pharma or medical device industry
  • 3 - 7 years experience performing the duties and responsibilities listed above
  • Knowledge of the functions and capabilities of data computing
  • Experience administering applications residing on Oracle, MS-SQL or MySQL
  • Skill in the use of Visual Basic programming or similar 3rd generation language


Preferred:
  • Experience implementing and validating systems in a regulated industry
  • Experience as a SharePoint administrator
  • Skill in both verbal and written communication
  • Knowledge of CFR and GCP/ICH requirements
  • Understanding of clinical drug development process
  • Excellent communication and organization skills
  • Ability to proactively plan, organize and function with minimal oversight


As the leading employer in our industry in the Pacific Northwest, Seattle Genetics is proud to offer a competitive total compensation package as well as a comprehensive benefits program designed to support the whole lives of our employees and their families. Benefits include medical, vision and dental coverage, group and supplemental life insurance, 401(k) with company match, tuition reimbursement, relocation assistance and much more. To learn more about Seattle Genetics, please visit www.seattlegenetics.com.

Seattle Genetics is an equal opportunity employer. All qualified applications will receive consideration for employment without regard to race, color, religion, sex, national origin, protected veteran status, or disability status.