Quality Assurance Associate

About the Company

A successful biotech company is hiring an experienced and detail-oriented Associate to join our Quality Assurance team on site in Bothell, WA. The role focuses on supporting commercial production to ensure consistent compliance with regulatory and industry expectations. Unfortunately, at this time no relocation or visa sponsorship is available.

As a Quality Assurance Associate, you will help maintain a quality-focused culture by ensuring documentation is complete, accurate, and stored in accordance with approved standard operating procedures and specifications. You will support the QA department in maintaining batch records and other key QA activities.

• Perform review of manufacturing batch records, enter information in Disposition Log, file batch records, and ensure records are retrievable.
• Conduct finished product inspection.
• Review and approve labels.
• Assist QA with tracking and completion of CAPAs, Customer Complaints, NCRs, OOSs, TMPs, and calibration/maintenance records.
• Track and file training forms; update the training log.
• Assist Document Control in assigning reference numbers, obtaining approvals, and auditing external documents.
• Perform other duties and tasks as assigned.

• Organizational Support – follows policies and procedures; completes administrative tasks on time.
• Quality – demonstrates accuracy and thoroughness; monitors own work to ensure quality.
• Written Communication – writes clearly and informatively; reads and interprets written information.

• Bachelor's degree (B.A. or B.S.) or equivalent combination of education and experience.
• Minimum of 2 years’ experience working in an FDA or ISO regulated environment or equivalent training.
• Knowledge of ISO 13485, ISO 9001, and FDA QSR preferred.

Associate

Full-time

Quality Assurance

Medical Equipment Manufacturing