Quality Assurance Associate II/III

Location
Bothell, Washington
Posted
Mar 08, 2018
Ref
oYk06fw8
Hotbed
BioForest
Required Education
Bachelors Degree
Position Type
Full time

Seattle Genetics is seeking a Quality Assurance Associate II/III at its North Creek facility. This QA Associate position will be responsible for supporting the operation and upkeep of the Document Control and Archival processes in support of GMP, GLP, and GCP activities. Core functions consist of day-to-day activities related to management of the Electronic Document Management System (EDMS) and physical documents housed in the QA Archive.

Responsibilities:

  • Assist in preparation and maintenance of GxP documents maintained within the EDMS including: writing, revising, and formatting of documents; issuance and reconciliation of periodic reviews; and management of the controlled documents workflows 
  • Assist with the creation and issuance of batch records, controlled forms, and controlled logbooks
  • Participate in the creation and revision of department operating procedures related to document control and archiving
  • Assist with the Logging, filing and retrieval of records in the Document Control Archive room
  • Assist with the packing, logging, and shipping of records to off-site storage locations
  • Assist with the implementation, management, and performance of scanning, uploading, and verification of digitized records within the EDMS
  • Identify, collect, and present metrics related to document control and archiving
  • Participate in new departmental initiatives and systems as needed

Qualifications:

  • Bachelor’s degree and 5+ years of relevant experience; or 8+ years of relevant experience
  • Strong computer skills with Microsoft Word and Excel, Adobe
  • Working knowledge of cGMP is required, including ability to understand regulatory guidances as they relate to document control and records management
  • Strong communication, organizational skills, and attention to detail
  • Strong teamwork skills
  • Ability to handle changing priorities in a fast paced environment

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.