QA Associate Site Based, Redmond, WA

Job Title: QA Associate

Location: Redmond WA (onsite)
Shifts: Days Mon to Fri 8 hour shifts ending 16:00

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 whats possible. Were on a mission to create a place where curiosity isnt just encouragedits celebrated.

Are you someone who asks questions seeks answers and isnt afraid to go deeper #BeCureious with us and see where your curiosity can take you!

The Role: / your challenge in our journey

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

The QA Associate role is responsible for the execution of day-to-day QA responsibilities for GMP manufacturing. This role works collaboratively with Manufacturing Quality and Facilities staff to ensure compliance with cGMPs and internal procedures.

What Youll 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.

Qualifications

• Bachelors 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

• Please be aware of the shifts for this role.

  Shifts: Days Mon to Fri 8 hour shifts ending 16:00

  with Ad-hoc days for business requirements.

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 is a site based role Redmond WA.

• 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 salaried non-exempt position at commencement of employment is expected to be $78000 to $82000; Base salary offered may vary depending on 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 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.