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

Evotec WD; Redmond (WA); Vor Ort; USD 55.000 - 102.000; Vollzeit

Benefits dieser Stelle

Flexible work options

Medical benefits

401k match

Paid time off

Zusammenfassung

Just Evotec Biologics is seeking a Quality Specialist, QMS in Redmond, WA. The role focuses on maintaining and improving QA/QMS processes, including Deviations, Change Control, CAPA, and regulatory inspections, with emphasis on data-driven decision making and cross-functional collaboration.

You will lead training, audits, and KPI reporting while ensuring compliance with cGMP. The position is site-based with a blend of hands-on and leadership responsibilities.

Qualifikationen

• Bachelor’s degree in biological or engineering science.
• Minimum 3 years in biopharmaceutical/cGMP manufacturing or similar.
• Experience in release and stability testing and qualification activities.
• Strong familiarity with eQMS tools and quality systems.

Aufgaben

• Assess and approve all quality events in eQMS (deviations, change control, CAPA, risk assessment, MBR, complaints).
• Communicate deliverable status to customers, management, and stakeholders.
• Deliver QA/QMS training for process or system changes.
• Support internal and external audits and regulatory inspections.
• Review and approve effectiveness checks for QMS with trend analysis.
• Execute process performance and product quality monitoring programs.
• Identify compliance issues and alert senior management of risks.

Kenntnisse

Quality systems

Deviations

Change control

CAPA

Risk assessment

Management review

Complaint investigation

Product quality review

QA audits

eQMS

G-QMS familiarity

MS Office

LIMS

CMMS

MES

Ausbildung

Bachelor’s degree in biological or engineering science

Tools

LIMS

CMMS

MES

Jobbeschreibung

Quality Specialist - QMSRedmond, WADepartment: QualityReports To: Senior Manager, QA QMS/QADShifts: Monday to Friday. 8 hrs. Usually 08:00-16:00About Us: this is who we areAt 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 journeyWe’re looking for a passionate and curious Quality Specialist, QMS 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 Quality Specialist, QMS 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: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 qualificationExperience in tools, concepts, and methodologies of QAStrong computer skills including Microsoft Office and eQMS databases, including LIMS, CMMS, MESKey competencies in verbal and written communication; attention to detail; data collection, management, and analysis; judgement and decision making; and building teams.Bachelor’s degree in biological or engineering scienceMinimum of 3 years relevant experience in a biopharmaceutical/Pharmaceutical cGMP manufacturing or similar environment.Ability to collaborate and communicate cross-functionally.Proven attention to detailWhy 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 roles will be site based in 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 BiologicsLet 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 $55,000-$102,000 annually. 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.