QA Specialist - QMS, Days, Site Based, Redmond, WA
About The Position
Just Evotec Biologics is seeking a Quality Specialist, QMS, to support its Quality department in Redmond, Washington. The role helps ensure quality-system processes comply with regulatory requirements and Just-Evotec Global Quality Management System requirements. It involves assessing and approving quality events, communicating deliverable status, providing training, supporting audits and inspections, monitoring process and product quality, and identifying compliance issues and opportunities for improvement. The position is site based and is scheduled Monday through Friday for eight hours, usually 08:00–16:00.
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 assessments, management reviews, complaint investigations, and product quality reviews, to ensure compliance with regulatory and Global Quality Management System requirements.
- Communicate the status of deliverables to customers, management, and stakeholders.
- Deliver training for 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.
- 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.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
