Research Associate II - Quality Control
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:
- Routine testing including in-process, release and stability testing of rapid and ELISA kits.
- Writing and revising QC test methods to ensure compliance with FDA and USDA regulations.
- Providing technical support for customer inquiries and/or complaints.
- Investigating and documenting CAPAs and other product/process quality issues
- Supporting method transfer and qualification activities.
- Statistical analysis of analytical/technical data
Qualifications for this position include:
- BS in Bioengineering, Chemistry, Biology or other relevant discipline.
- Minimum of 2 years QC experience in a GMP and manufacturing environment. This is not an entry-level position.
- Excellent knowledge of statistics. Ability to analyze, evaluate and report technical data to upper management.
- Ability to interact constructively with co-workers. Excellent verbal & written communication skills are a must.
- Ability to troubleshoot assays.
- Experience running ELISA and rapid immunoassays as well as other commonly used assays in a QC environment.
- 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.
- Familiarity with process validation is a plus.
- Experience using MS Word and Excel.
- 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.