Curious QA & QMS Specialist | Biopharma

Evotec SE; Union Hill-Novelty Hill (WA); Sur place; USD 55 000 - 102 000; Plein temps

Avantages offerts par ce poste

Growth Opportunities

Flexible Work Environment

Inclusive Culture

Innovative Projects

A Place for Big Ideas

Résumé du poste

Just Evotec Biologics in Redmond, WA seeks a Quality Specialist, QMS to drive compliance across Deviations, CAPA, Change Control, and audits. You’ll collaborate with QA, Manufacturing, and R&D to ensure product quality and regulatory readiness.

The role requires at least 3 years in a biopharmaceutical/cGMP setting, strong knowledge of QMS and laboratory testing, and solid communication skills. This is a site-based opportunity with regular daytime hours.

Qualifications

• Bachelor’s degree in biological or engineering science.
• 3+ years in biopharmaceutical/cGMP environment.
• Knowledge of regulatory requirements and risk management.
• Experience with QC activities and laboratory testing.
• Strong communication and cross-functional collaboration.

Responsabilités

• Assess and approve quality events in eQMS to ensure compliance with gQMS requirements.
• Communicate status of deliverables to customers, management, and stakeholders.
• Deliver training for QMS processes or system changes.
• Support internal and external audits and regulatory inspections.
• Review effectiveness checks, trend data, and KPIs for continuous improvement.
• Execute process performance and product quality monitoring programs.
• Identify potential compliance issues and escalate appropriately.
• Alert senior management to significant risks.

Connaissances

Quality infrastructure

Regulatory knowledge

Laboratory testing

Communication

Cross-functional collaboration

Formation

Bachelor’s degree in biological or engineering science

Outils

LIMS

CMMS

MES

eQMS

Microsoft Office

Description du poste

Just Evotec Biologics in Redmond, WA seeks a Quality Specialist, QMS to drive compliance across Deviations, CAPA, Change Control, and audits. You’ll collaborate with QA, Manufacturing, and R&D to ensure product quality and regulatory readiness.

The role requires at least 3 years in a biopharmaceutical/cGMP setting, strong knowledge of QMS and laboratory testing, and solid communication skills. This is a site-based opportunity with regular daytime hours.