Quality Systems & Training Specialist

Grifols Shared Services North America, Inc; Edinburg (TX); On-site; USD 55,000 - 75,000; Full time

Job summary

Grifols seeks a Quality Systems Associate to support QA and training within a donor center setting in North America. The role emphasizes compliance with cGMP, SOPs, and regulatory requirements while ensuring product quality and donor safety.

Under supervision, you will review equipment records, investigate deviations and customer complaints, and assist with audits and training programs. This position requires attention to detail and the ability to work within a regulated environment.

Qualifications

• High school diploma or GED.
• State licensures or certifications if applicable.
• Typically no prior related experience required.

Responsibilities

• Completes weekly review of equipment QC and maintenance records.
• Documents, investigates, and performs root-cause analysis for deviations and customer complaints.
• Inspects and releases incoming supplies; investigates nonconforming items.
• Performs documentation review for unsuitable test results.
• Assists with cGMP, SOPs and regulatory compliance.
• Performs all product release activities.
• Reviews lookback information and donor center documentation.

Skills

Interpersonal skills

Organizational skills

Problem solving

FDA regulations

Quality & compliance

Mathematics

Legible handwriting

Computers

Flex scheduling

Documentation review

cGMP knowledge

Education

High school diploma or GED

Job description

Grifols seeks a Quality Systems Associate to support QA and training within a donor center setting in North America. The role emphasizes compliance with cGMP, SOPs, and regulatory requirements while ensuring product quality and donor safety.

Under supervision, you will review equipment records, investigate deviations and customer complaints, and assist with audits and training programs. This position requires attention to detail and the ability to work within a regulated environment.