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

Evotec; Redmond (WA); On-site; USD 55,000 - 102,000; Full time

Job summary

Just Evotec Biologics is seeking a passionate Quality Specialist, QMS to join its team in Redmond, WA. You will drive regulatory-compliant QA activities, manage deviations, CAPA, and change controls, and support audits and inspections.

The role requires a 3+ year background in biopharma cGMP, a biological or engineering science degree, and strong skills in eQMS, LIMS, CMMS, and MES. Collaboration and attention to detail are essential for success.

Qualifications

• Bachelor's degree required in biological or engineering science.
• Minimum 3 years in biopharmaceutical/cGMP environment.
• Experience with QA processes and QMS.
• Experience with laboratory testing and regulatory requirements.

Responsibilities

• Assess and approve quality events in eQMS (Deviations, Change Control, CAPA, Risk Assessment, Management Review, Complaint Investigation, PQR) to ensure regulatory compliance.
• Provide communication on deliverables status to customers, management and stakeholders.
• Deliver training for QMS processes or system changes.
• Support internal and external audits and regulatory inspections.
• Review and approve effectiveness checks for QMS through trends, analysis, and KPIs.
• Execute process performance and product quality monitoring programs.
• Identify potential compliance issues and alert senior management.

Skills

Quality mindset

Cross-functional collaboration

Attention to detail

Communication skills

Education

Bachelor's degree in biological or engineering science

Tools

LIMS

CMMS

MES

eQMS databases

Job description

About Us

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.

The Role

We'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 qualification
• Experience in tools, concepts, and methodologies of QA
• Strong computer skills including Microsoft Office and eQMS databases, including LIMS, CMMS, MES
• Bachelor's 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

Key competencies in verbal and written communication; attention to detail; data collection, management, and analysis; judgement and decision making; and building teams.

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 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.

Base Pay and Benefits

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,