Quality Systems Specialist: Plasma Center QA & Training

Grifols; North Carolina; On-site; USD 42,000 - 64,000; Full time

Job summary

Grifols is seeking a Quality Systems Associate in North Carolina to support quality assurance and training under the Quality Systems Manager. The role ensures compliance with cGMP, SOPs, and regulatory requirements, performing QA activities and assisting with product release and documentation reviews.

You will review equipment QC, investigate deviations and donor safety issues, manage training records, and participate in internal audits and center notifications.

Qualifications

• High school diploma or GED required.
• No prior related experience typically required.
• Ability to understand FDA regulations.
• Strong attention to detail and documentation accuracy.

Responsibilities

• Completes weekly review of equipment QC and maintenance records.
• Documents, investigates, and performs root-cause analysis for deviations and customer complaints affecting product quality or donor safety.
• Inspects and releases incoming supplies; reports supplies not meeting specifications.
• Performs documentation review for unsuitable test results.
• Assists with cGMP compliance, SOP adherence, and regulatory requirements.
• Under supervision, performs quality assurance and training duties.
• Performs product release activities.
• Reviews donor charts, waste documentation, and regulatory-related records.
• Supports internal audits and center notifications.

Skills

Regulatory compliance

Documentation review

Root-cause analysis

Quality systems

cGMP knowledge

Detail oriented

Interpersonal skills

Education

High school diploma or GED

Job description

Grifols is seeking a Quality Systems Associate in North Carolina to support quality assurance and training under the Quality Systems Manager. The role ensures compliance with cGMP, SOPs, and regulatory requirements, performing QA activities and assisting with product release and documentation reviews.

You will review equipment QC, investigate deviations and donor safety issues, manage training records, and participate in internal audits and center notifications.