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

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

Shifts: Day Shift MondayFriday Core Hours 8:00am5:30pm
Location: Redmond Seattle WA (Onsite)

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

If youre someone who asks bold questions seeks meaningful answers and isnt afraid to dive deep into complex problemsyour curiosity belongs here.
#BeCurious with us.

The Role: Your Challenge in Our Commercialization Journey
We are seeking a GMP focused Raw Material Quality Senior Specialist to support QC operations for late stage and commercial biologics 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 provide 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.

What Youll Do (GMP Heavy Responsibilities)

• 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 ProcessDevelopmentand EH&S functions to ensure thorough assessment of raw materials and associated investigations in support of product quality and patient safety.

• Support audit andinspectionreadiness including support and preparation of responses to observations and ensuring response CAPAs are effective.

• Drive planning coordination and continuous improvement of processes and systems toassurethe 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.

Who You Are (Qualifications & Competencies) Requirements

• BS in Chemistry or related fieldwith 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 investigation process and science-based decision making.

• 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.

• Must demonstrate initiative resourcefulness and flexibility to work independently and as part of a team.

Why Join Us:

• Growth Opportunities: Were a company that believes in continuous learning and development. Whether its professional courses mentorship or new projects well help you grow.
• Flexible Work Environment: We offer flexible work options to help you balance your professional and personal life. This role is site based.
• Inclusive Culture: Were committed to building a diverse and inclusive environment where everyones voice is valued and curiosity is encouraged.
• Innovative Projects: Youll have the chance to work on groundbreaking initiatives and cutting-edge technology in an atmosphere where your curiosity is the key to success.
• A Place for Big Ideas: We dont just talk about thinking outside the boxwe throw the box away. If youve got ideas we want to hear them.

Are You Still Curious

If youve read this far then chances are youve got a curious mindjust like us. So what are you waiting for Take the leap and apply today. We cant wait to see where your curiosity leads youand how it will shape the future of Just Evotec Biologics.

Let your curiosity guide your career#BeCurious and explore the endless possibilities at Just Evotec Biologics!

The base pay range for this position at commencement of employment is expected to be $92400 to $126500;this is a salary exempt role. Base salary offered may vary depending on the individuals skills experience and competitive market value. Additional total rewards include discretionary annual bonus 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.

Evotec (US) Inc. is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race gender age disability genetic information gender expression gender identity national origin religion sexual orientation or veteran status.