QA Specialist QMS, Days, Site Based, Redmond, WA

Quality Specialist - QMS

Redmond WA

Department: Quality

Reports To: Senior Manager QA QMS/QAD

Shifts: Monday to Friday. 8 hrs. Usually 08:00-16:00

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 Quality Specialist QMS 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.

As a Quality Specialist QMS at Just Evotec Biologics youll have the freedom to ask the hard questions think outside the box and find creative solutions that push us forward. Its a role where your curiosity will fuel both your personal growth and the success of the team.

What Youll Do:

• Assess and approve all quality events in 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.
• Provides communication as to the status of deliverables to customers management and stakeholders.
• Deliver training for QMS process or system changes.
• Provide QA QMS in supporting internal and external client audits and regulatory inspections.
• Review and approve effectiveness checks 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.
• Execute process performance and product quality monitoring programs.
• Identify potential compliance issues.
• Alert senior management of significant quality compliance supply or safety risks.

Who You Are:

• Experience in helping to maintain a Quality infrastructure in a fast-paced growing company.
• Understanding of biologics regulatory requirements risk management principles and science-based decision making.
• Experience in laboratory testing such as: SEC UHPLC Potency and Residual Protein (ELISA) Osmolality Solo VPE Capillary Electrophoresis (SDS/rCE-SDS) Assay (icIEF)
• Experience in release testing stability testing equipment qualification and method qualification
• Experience in tools concepts and methodologies of QA
• Strong computer skills including Microsoft Office and eQMS databases including LIMS CMMS MES
• Key competencies in verbal and written communication; attention to detail; data collection management and analysis; judgement and decision making; and building teams.
• Bachelors degree in biological or engineering science
• Minimum of 3 years relevant experience in a biopharmaceutical/Pharmaceutical cGMP manufacturing or similar environment.
• Ability to collaborate and communicate cross-functionally.
• Proven attention to detail

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 roles will be site based in 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 #BeCUREious 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 $55000-$102000 annually. 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.

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.

Required Experience:

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