Senior QC Analyst

Job Summary

A company is looking for a Senior QC Analyst in Bothell, WA.

Key Responsibilities:

• Manage small molecule drug testing, method transfer, qualification/validation, and support regulatory submission activities
• Collaborate with internal colleagues and external testing labs for small molecule Intermediate, API, and Drug Product
• Manage quality investigations, assay study design, and technical report writing

Required Qualifications:

• BS or MS in life science field with 5+ years (MS) or 8+ years (BS) working experience in pharmaceutical or biotech field
• Excellent analytical skills with hands-on experience in analytical methods such as HPLC, UPLC, GC, and USP compendial testing
• Strong method troubleshooting skills and scientific understanding of chemistry or analytical chemistry
• Familiarity with regulatory filings such as IND, IMPD, and NDA
• Prior working experience in a regulated environment (GMP, GLP, etc.) is preferred