Research Associate II - Quality Control

Seattle, Washington
Depends on experience
Mar 12, 2018
Required Education
Bachelors Degree
Position Type
Full time

A growing Seattle biotech company, currently in Pioneer Square but shortly to relocate to the dynamic South Lake Union area, is looking for an experienced, high-performance, quality-oriented individual to work in the Quality Department.  This person will be responsible for:

  1. Routine testing including in-process, release and stability testing of rapid and ELISA kits.
  2. Writing and revising QC test methods to ensure compliance with FDA and USDA regulations.
  3. Providing technical support for customer inquiries and/or complaints.
  4. Investigating and documenting CAPAs and other product/process quality issues
  5. Supporting method transfer and qualification activities.
  6. Statistical analysis of analytical/technical data

Qualifications for this position include:

  1. BS in Bioengineering, Chemistry, Biology or other relevant discipline. 
  2. Minimum of 2 years QC experience in a GMP and manufacturing environment. This is not an entry-level position.
  3. Excellent knowledge of statistics.  Ability to analyze, evaluate and report technical data to upper management.
  4. Ability to interact constructively with co-workers.  Excellent verbal & written communication skills are a must.
  5. Ability to troubleshoot assays.
  6. Experience running ELISA and rapid immunoassays as well as other commonly used assays in a QC environment.
  7. Excellent knowledge of GMP/GLP regulations as it pertains to QC.  Knowledge of ISO13485, FDA 21 CFR Part 820, and/or USDA regulations a plus.
  8. Familiarity with process validation is a plus.
  9. Experience using MS Word and Excel. 
  10. Demonstrated ability to take ownership of QC goals and projects with excellent attention to detail and the ability to be flexible and to multi-task.