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.
Requirements
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
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 : 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.
Are You Still Curious?
If you've read this far, then chances are you've got a curious mind-just like us. So, what are you waiting for? Take the leap and apply today. We can't wait to see where your curiosity leads you-and 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 !
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 orien
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 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: / your challenge, ...in our journey
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.
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.
Evotecgroup · Redmond