QA Associate - Quality Assurance - Site Based, Swing Shifts - Starting 12noon.

Evotec SE; Redmond (WA); Sur place; USD 78 000 - 82 000; Plein temps

Avantages offerts par ce poste

Growth opportunities

Flexible work environment

Inclusive culture

Competitive benefits

Résumé du poste

Just Evotec Biologics in Redmond, WA is seeking a QA Associate to join the Quality Department. You will review batch records, support QA/QMS activities, and partner with Manufacturing to ensure compliance across operations.

This role offers growth opportunities and a collaborative, cross-functional environment. The ideal candidate has a bachelor’s degree in a life science field and at least 2 years in a biopharmaceutical manufacturing setting, with strong attention to detail and communication

Qualifications

• Bachelor’s degree in biological sciences, chemistry, biochemistry, engineering, or related life science field.
• Minimum of 2 years relevant experience in a biopharmaceutical/Pharmaceutical cGMP manufacturing or similar environment.
• Strong attention to detail.
• Ability to collaborate and communicate cross-functionally.

Responsabilités

• Review executed Manufacturing Batch Records.
• Participate in compliance walkthrough of the Manufacturing floor and other assigned areas.
• Partner with Manufacturing to ensure compliance in Manufacturing operations.
• Review and approve Master Batch Records and other supporting documents.
• Execute process performance and product quality monitoring programs.
• Alert senior management of potential deviations or compliance risks.
• Initiate and review all quality events of eQMS to assure compliance with regulatory and Just-Evotec Global Quality Management Systems.
• Support QA QMS in internal and external client audits and regulatory inspections.
• Monitor effectiveness for QMS through trending, analysis, and metrics; report to top management and G-QMS on KPIs.
• Act as the QA representative on cross-functional product teams to integrate stability activities with project milestones.

Connaissances

Attention to detail

Cross-functional collaboration

Biopharmaceutical manufacturing

Quality systems

Formation

Bachelor’s degree in biological sciences, chemistry, biochemistry, engineering, or related life science field

Description du poste

Job Title: QA Associate

Location: Redmond, WA

Department : Quality

Reports To : Quality Manager

Shifts: Days, Wed to Sat, 10 hour shifts, starting 12noon 22:00pm, with Ad-hoc days for business requirements.

About Us:

this is who we are

At Just Evotec Biologics , we believe that curiosity is the spark that drives innovation and success. As a forward-thinking team, we thrive on challenging the status quo, learning from each other, and pushing the boundaries of what’s possible. We're on a mission to create a place where curiosity isn't just encouraged—it’s celebrated.

Are you someone who asks questions, seeks answers, and isn't afraid to go deeper? #BeCureious with us and see where your curiosity can take you!

The Role:

We’re looking for a passionate and curious QA Associate to join our team. If you’re excited by new challenges, solving complex problems, and learning every step of the way, you might just be the perfect fit. In this role, you’ll have the opportunity to drive impactful projects, collaborate with bright minds, and explore uncharted territories.

As a QA Associate at Just Evotec Biologics, you'll have the freedom to ask the hard questions, think outside the box, and find creative solutions that push us forward. It’s a role where your curiosity will fuel both your personal growth and the success of the team.

What You’ll Do:

• Review executed Manufacturing Batch Records.
• Participate in compliance walkthrough of the Manufacturing floor and other assigned areas.
• Partner with Manufacturing to ensure compliance in Manufacturing operations.
• Review and approve Master Batch Records and other supporting documents.
• Execute process performance and product quality monitoring programs.
• Alert senior management of potential deviations or compliance risks.
• Initiate and review all quality events of eQMS (Deviations, Change Control, CAPA, Risk Assessment, Management Review, Complaint Investigation, Product Quality Review etc.) to assure compliance with regulatory and Just-Evotec Global Quality Management Systems (G-QMS) requirements.
• Support QA QMS in internal and external client audits and regulatory inspections (including but not limited to SME for QMS processes and individual records).
• Monitor effectiveness for QMS through trending, analysis, and metrics; report to top management and G-QMS on the performance of the KPIs and identify opportunities for continuous improvement.
• Act as the QA representative on cross-functional product teams to integrate stability activities with project milestones.

Who You Are:

• Bachelor’s degree in biological sciences, chemistry, biochemistry, engineering, or related life science field.
• Minimum of 2 years relevant experience in a biopharmaceutical/Pharmaceutical cGMP manufacturing or similar environment.
• Strong attention to detail
• Ability to collaborate and communicate cross-functionally.

Why Join Us:

• Growth Opportunities : We’re a company that believes in continuous learning and development. Whether it’s professional courses, mentorship, or new projects, we’ll help you grow.
• Flexible Work Environment : We offer flexible work options to help you balance your professional and personal life. This is a site based role, Redmond, WA.
• Inclusive Culture : We’re committed to building a diverse and inclusive environment where everyone’s voice is valued, and curiosity is encouraged.
• Innovative Projects : You’ll 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 don’t just talk about thinking outside the box—we throw the box away. If you’ve got ideas, we want to hear them.

If you’ve read this far, then chances are you’ve got a curious mind—just like us.

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

The base pay range for this non-exempt position at commencement of employment is expected to be $78,000-$82,000. Base salary offered may vary depending on individual's 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, flexible work, 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.

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.