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

Evotec•Redmond, WA

4d•Onsite

About The Position

Just Evotec Biologics is seeking a curious and passionate Quality Specialist, QMS, to join its Quality team in Redmond, Washington. This site-based role supports the company’s Quality Management System and helps ensure compliance with regulatory requirements and Just-Evotec Global Quality Management Systems. The position reports to the Senior Manager, QA QMS/QAD and is scheduled Monday through Friday for eight hours, usually 08:00–16:00. The Quality Specialist assesses and approves quality events in the electronic QMS, including deviations, change controls, CAPAs, risk assessments, management reviews, complaint investigations, and product quality reviews. The role also communicates deliverable status, provides training on QMS process or system changes, supports client audits and regulatory inspections, reviews effectiveness checks and performance metrics, and contributes to process performance and product quality monitoring. The specialist identifies potential compliance issues and escalates significant quality, compliance, supply, or safety risks to senior management. The successful candidate will bring experience maintaining quality infrastructure in a fast-paced, growing organization, knowledge of biologics regulatory requirements and risk management, and relevant experience in a biopharmaceutical or pharmaceutical cGMP manufacturing or similar environment. This position offers opportunities for learning and development, collaboration on innovative projects, and participation in an inclusive, curiosity-driven culture.

Requirements

Bachelor’s degree in biological or engineering science.
At least 3 years of relevant experience in a biopharmaceutical or pharmaceutical cGMP manufacturing or similar environment.
Experience helping maintain a Quality infrastructure in a fast-paced, growing company.
Understanding of biologics regulatory requirements, risk management principles, and science-based decision making.
Experience with laboratory testing such as SEC UHPLC, potency and residual protein (ELISA), osmolality, Solo VPE, capillary electrophoresis (SDS/rCE-SDS), and assay (icIEF).
Experience in release testing, stability testing, equipment qualification, and method qualification.
Experience with QA tools, concepts, and methodologies.
Strong computer skills, including Microsoft Office and eQMS databases, including LIMS, CMMS, and MES.
Verbal and written communication skills, attention to detail, data collection, management and analysis, judgment and decision-making, and team-building competencies.
Ability to collaborate and communicate cross-functionally.
Proven attention to detail.

Responsibilities

Assess and approve quality events in eQMS, including deviations, change control, CAPA, risk assessment, management review, complaint investigation, and product quality review, to ensure compliance with regulatory and Just-Evotec Global Quality Management System requirements.
Communicate the status of deliverables to customers, management, and stakeholders.
Deliver training on QMS process or system changes.
Support internal and external client audits and regulatory inspections as part of QA QMS.
Review and approve QMS effectiveness checks through trending, analysis, and metrics.
Report KPI performance to top management and G-QMS, and identify opportunities for continuous improvement.
Execute process performance and product quality monitoring programs.
Identify potential compliance issues.
Alert senior management to significant quality, compliance, supply, or safety risks.

Benefits

Professional courses, mentorship, and new projects to support growth and development.
Flexible work options.
Inclusive work environment.
Opportunity to work on innovative initiatives and cutting-edge technology.
Discretionary annual bonus.
Medical, dental, and vision benefits.
Short-term and long-term disability coverage.
Company-paid basic life insurance.
401(k) company match.
Generous paid time off and paid holidays.
Wellness benefits.
Transportation benefits.