Raw Materials Quality Senior Specialist - Site Based, Redmond & Seattle, WA

Job Title: Raw Material Quality Senior Specialist – Quality Control (GMP). Seeking a GMP focused Raw Material Quality Senior Specialist to support QC operations for late stage and commercial biologics manufacturing. Ensure the quality, consistency, and regulatory compliance of raw materials across Seattle and Redmond GMP facilities.

Requirements

• BS in Chemistry or related field with 5+ years relevant Quality experience in GMP biopharmaceutical or biotechnology industry.
• Materials science background and understanding of chemical compatibility and extractables/leachables requirements.
• Strong understanding of cGMP, FDA, and EMA regulations for raw materials and relevant ICH, ISO, and USP/EU/JP compendial guidance.
• Experience supporting regulatory compliance inspections and responses.
• Ability to interpret, assess, and effectively communicate impact of raw materials and associated results on process data.
• Strong focus on quality and attention to detail as well as effective time management and organizational skills.
• Key competencies in verbal and written communication, data analysis, judgement and decision making, and building teams.
• Strong computer skills including Microsoft Office Suite (Excel, Word, PowerPoint) and eQMS databases.
• Ability to adapt, work in a fast-paced environment, and concurrently manage multiple projects and priorities.

Benefits

• Comprehensive benefits to include Medical, Dental and Vision, short-term and long-term disability, company paid basic life insurance, 401k company match, generous paid time off and paid holiday, wellness and transportation benefits.
• Discretionary annual bonus