QA Specialist, Operations - Site Based Seattle, WA

Role Summary

QA Specialist - Operations, site-based in Seattle, WA. Responsible for day-to-day QA activities for GMP manufacturing and for building and enhancing quality assurance systems, working with Manufacturing, Quality and Facilities to ensure compliance with cGMPs.

Responsibilities

• Review executed Manufacturing Batch Records
• Execute compliance walkthrough of the Manufacturing floor and other assigned areas
• Participate in the training of new or junior staff
• Partner with Manufacturing to ensure compliance in Manufacturing operations
• Triage Manufacturing events and support event investigations
• Review and approve Master Batch Records and other supporting documents
• Support internal and client audits
• Execute process performance and product quality monitoring programs
• Alert senior management of significant quality, compliance, supply, and safety risks

Qualifications

• Bachelor’s degree in biological or engineering science
• Minimum of 3 years relevant experience in a biopharmaceutical/Pharmaceutical cGMP manufacturing or similar environment
• Ability to collaborate and communicate cross-functionally
• Proven attention to detail