Quality Systems Specialist – QA, Training & Compliance

Grifols; Everett (WA); On-site; USD 34,000 - 46,000; Full time

Benefits offered by this job

Medical

Dental

Vision

Life insurance

PTO

Holidays

401(k) match

Tuition reimbursement

Job summary

Grifols is seeking a Quality Systems Associate in Everett, WA to support quality assurance and training functions, ensuring compliance with internal and external regulations. The role involves reviewing equipment QC, investigating deviations, and ensuring proper documentation for donor center processes.

The position requires adherence to cGMP, SOPs, and regulatory requirements, with responsibilities spanning product release, training records, and center audits.

Qualifications

• High school diploma or GED; state licensures or certifications if applicable.
• Understanding of FDA regulations and quality systems (cGMP) is beneficial.
• Strong attention to detail with solid organizational skills.
• Ability to work in a plasma center environment with exposure to biological materials.

Responsibilities

• Completes weekly review of equipment QC and maintenance records.
• Documents, investigates, and performs root‑cause analysis for deviations and customer complaints related to product quality and donor safety.
• Inspects and releases incoming supplies; investigates and reports supplies not meeting quality specs.
• Performs documentation review for unsuitable test results.
• Assists with cGMP compliance, SOPs and regulatory requirements; follows SOPs and training documents.
• Performs all product release activities and reviews lookback information, waste shipment documentation, and donor events/deferrals.
• Reviews electronic donor chart exceptions impacting donor eligibility/safety and product quality.

Skills

Interpersonal communication

Organizational skills

Problem solving

FDA regulations understanding

Mathematics

Computer proficiency

Attention to detail

Education

High school diploma or GED

Job description

Grifols is seeking a Quality Systems Associate in Everett, WA to support quality assurance and training functions, ensuring compliance with internal and external regulations. The role involves reviewing equipment QC, investigating deviations, and ensuring proper documentation for donor center processes.

The position requires adherence to cGMP, SOPs, and regulatory requirements, with responsibilities spanning product release, training records, and center audits.