QA/QMS Specialist — Biopharma, Flexible Work

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

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.