Quality QMS Specialist – Biologics, Growth & Impact

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

Benefits offered by this job

Flexible work options

Medical benefits

401k match

Paid time off

Job summary

Just Evotec Biologics is seeking a Quality Specialist, QMS in Redmond, WA. The role focuses on maintaining and improving QA/QMS processes, including Deviations, Change Control, CAPA, and regulatory inspections, with emphasis on data-driven decision making and cross-functional collaboration.

You will lead training, audits, and KPI reporting while ensuring compliance with cGMP. The position is site-based with a blend of hands-on and leadership responsibilities.

Qualifications

• Bachelor’s degree in biological or engineering science.
• Minimum 3 years in biopharmaceutical/cGMP manufacturing or similar.
• Experience in release and stability testing and qualification activities.
• Strong familiarity with eQMS tools and quality systems.

Responsibilities

• Assess and approve all quality events in eQMS (deviations, change control, CAPA, risk assessment, MBR, complaints).
• Communicate deliverable status to customers, management, and stakeholders.
• Deliver QA/QMS training for process or system changes.
• Support internal and external audits and regulatory inspections.
• Review and approve effectiveness checks for QMS with trend analysis.
• Execute process performance and product quality monitoring programs.
• Identify compliance issues and alert senior management of risks.

Skills

Quality systems

Deviations

Change control

CAPA

Risk assessment

Management review

Complaint investigation

Product quality review

QA audits

eQMS

G-QMS familiarity

MS Office

LIMS

CMMS

MES

Education

Bachelor’s degree in biological or engineering science

Tools

LIMS

CMMS

MES

Job description

Just Evotec Biologics is seeking a Quality Specialist, QMS in Redmond, WA. The role focuses on maintaining and improving QA/QMS processes, including Deviations, Change Control, CAPA, and regulatory inspections, with emphasis on data-driven decision making and cross-functional collaboration.

You will lead training, audits, and KPI reporting while ensuring compliance with cGMP. The position is site-based with a blend of hands-on and leadership responsibilities.