Quality Control Analyst III

Global Quality Bothell, Washington


Description

Summary:  
 
The Quality Control Analyst III will support daily equipment management operations to ensure equipment are available for QC to use for testing and ensure equipment are maintained in accordance with standard operating procedures (SOPs) in a cGMP compliant QC laboratory. 
 
Principal Responsibilities: 
 

  • Ensure equipment is managed in accordance with governing procedures 
  • Review completed equipment-related tasks in the CMMS (computerized maintenance management system) 
  • Launch change control records for document and/or equipment changes 
  • Address equipment alarms such as for temperature excursions including moving material to alternate storage unit and assist in alarm investigations 
  • Assist Equipment System Owners with purchasing equipment 
  • Assist Equipment System Owners with periodic reviews of equipment and software. 
  • Perform equipment logbook reviews 
  • Coordinate with Facilities for scheduling calibration, maintenance, and repairs 
  • Evening, weekend, and/or on-call work may be required 
  • May act as System Owner for some transactions in the CMMS 
  • May take lead role for some equipment periodic reviews 
  • May take lead role for some equipment change control records 
  • May assist with samples management including but not limited to physical sample/material handling, shipping/receiving, maintaining chain of custody, and routine maintenance/cleaning of biosafety cabinets, freezers, and refrigerators 

Required Qualifications: 
 

  • 5+ years equipment use and/or management experience 
  • Strong troubleshooting skills 
  • Experience authoring or revising Standard Operating Procedures 
  • Familiarity with Change Control 
  • Be highly organized with an attention to detail 
  • Ability to keep order of multiple projects/tasks 
  • Experience with Blue Mountain, Maximo, or other equipment maintenance management system 
  • Experience using or managing analytical lab equipment (pH meters, balances, HPLCs, etc.) 

Preferred Experience: 

  • 2+ years of experience working in a GMP laboratory 
  • GMP experience 

 

As the leading employer in our industry in the Pacific Northwest, Seagen 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 Seagen, please visit www.seagen.com.  

Seagen is an equal opportunity employer. All qualified applications will receive consideration for employment without regard to race, age, gender identity, sexual orientation, color, religion, sex, marital status, national origin, protected veteran status, disability status, or any other status protected by federal, state, or local law.  

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