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

Job Title: Raw Material Quality Senior Specialist – Quality Control (GMP)

Shifts: Day Shift, Monday–Friday, Core Hours 8:00am–5:30pm

Location: Redmond, Seattle WA (Onsite)

At Just Evotec Biologics, curiosity fuels everything we do. We challenge assumptions, explore new ideas, and push the boundaries of what’s possible in biologics development and manufacturing. As we prepare for Process License Inspections (PLI) and transition toward commercial readiness, we’re building a team that thrives on scientific rigor, operational excellence, and a deep commitment to quality.

We are seeking a GMP focused Raw Material Quality Senior Specialist to support QC operations for late stage and commercial biologics manufacturing. In this role, you will be a key contributor to ensuring the quality, consistency, and regulatory compliance of raw materials across our Seattle and Redmond GMP facilities.

You will play a critical role in new raw material onboarding, impact assessment and process change implementation in response to supplier, material, compendial, and guideline changes—all essential to our path toward commercialization.

This is a role for someone who is both scientifically sharp and operationally disciplined, who can think creatively while executing flawlessly in a regulated environment.

The Raw Material Quality Senior Specialist will implement user requirements, risk assessments, and raw material specification documents through coordination across internal functions and suppliers in support of our GMP manufacturing operations at the Seattle and Redmond, WA GMP facilities. These efforts support GMP manufacturing activities for biotherapeutic products.

• Apply knowledge and experience to drive supplier and material onboarding activities and change management in accordance with approved procedures, industry standard and current regulatory requirements.
• Investigate internal GMP supplier quality events (e.g., deviations, CAPAs) with escalation of critical issues with potential to affect patient safety, product quality, or supply.
• Assess supplier change notifications and initiate/process any follow-up actions necessary to determine impact and ensure compliance.
• Support supplier onboarding audits, qualification, and routine performance monitoring audits.
• Create, update and obsolete material specifications and procedures as needed.
• Initiate and assess change controls for impact to supplier quality management, process impact, and patient safety.
• Lead in raw material risk assessments, including assessment of extractables/leachables.
• Collaborate Supplier Quality Management, Quality Control, Manufacturing Operations, Technical Operations, Materials Management, F&E, Process Development and EH&S functions to ensure thorough assessment of raw materials and associated investigations in support of product quality and patient safety.
• Support audit and inspection readiness, including support and preparation of responses to observations and ensuring response CAPAs are effective.
• Drive planning, coordination, and continuous improvement of processes and systems to assure the quality of released raw materials.
• Provide communication as to the status of deliverables to customers, management, and stakeholders.
• Participate in daily and weekly operational meetings to support raw material supply and issue resolution.

• 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.
• Understanding of process equipment and operations needs to manufacture biotherapeutics and supporting analytics to qualify and release raw materials.
• Comprehensive understanding of biologics regulatory requirements, risk management principles,…