Quality Control Analyst I/II, Raw Materials

Bothell, Washington
Mar 08, 2018
Quality, Quality Control
Required Education
Bachelors Degree
Position Type
Full time

This QC analyst position will be located at Seattle Genetics North Creek facility, and will perform testing to support cGMP manufacturing.


This position is located within the Quality Control (QC) department and is responsible for daily laboratory operations and assuring that raw materials used in manufacturing can be consistently supplied and are of the appropriate quality to ensure the production of drug substance meets or exceeds expectations while maintaining compliance with Quality Assurance (QA) policies and procedures, cGMPs, and SOPs.

Job scope:

  • Perform sampling, inspection and disposition testing of GMP raw materials
  • Conduct routine and non-routine analyses of raw materials and manufacturing aids in accordance with standard operating procedures (SOPs) orcompendial methods in a cGMP compliant QC laboratory, and acts as a liaison with contract testing facilities in this capacity


Requirements (technical skills, key characteristics, education, etc.):

  • BA or BS in science field with 1+ years working experience in pharmaceutical or biotech field
  • Strong time management skills with attention to details and desire to achieve team and individual goals
  • Be comfortable working in a team environment and interacting with other team members within the group and other departments of the company
  • Be able to handle multiple tasks in an organized and time-efficient manner
  • Strong attention to detail
  • Careful and fastidious
  • Strong computer skills and working knowledge of general MS Office applications
  • Demonstrate good communication skills, both written and verbal
  • Be willing to work with a team to complete a job and proactively implement continual improvements 

Additional Skills (competencies and desirable capabilities):

  • Experience working with LIMS
  • Experience with sample chain of custody procedures including shipping and receiving of biological, chemical and raw material samples
  • Experience reviewing analytical data in a regulated environment (GMP, GLP, GCP, etc.)
  • Knowledge and hands on experience of biological and/or chemical assays
  • Familiarity with the development and implementation of new laboratory systems and analysis techniques with particular focus on HPLC, FT-IR/Raman, UV and USP/EP Compendial Methods
  • Familiarity in the development, generation and implementation of raw material and manufacturing aid specifications for materials used in a clinical manufacturing setting
  • Knowledge of cGMP regulations

 Physical Requirements (i.e. routine travel, lifting over 30 lbs., etc.): 

  • Occasional lifting and moving containers greater than 20 lbs may be required

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.