Quality Assurance & Training Specialist

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

Job summary

Grifols Shared Services North America, Inc. seeks a Quality Systems Associate to support quality assurance and training functions within a donor center environment.

Under supervision, you will ensure adherence to cGMP, SOPs, and regulatory requirements while performing product release activities and documenting deviations. The role emphasizes reviewing donor center records, training audits, and maintaining compliance with internal standards.

Qualifications

• High school diploma or GED; state licensures or certifications if applicable.
• Typically no previous related experience required.
• Familiarity with FDA regulations and cGMP concepts preferred.
• Ability to review documentation and conduct accurate, detailed records.

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.
• Supports training programs and SOP adherence under supervision.
• Performs product release activities as needed.
• Reviews lookback information, donor center audits, and adverse event reports.
• Ensures proper freezing, storage, and handling documentation for plasma products.

Skills

Interpersonal communication

Organizational skills

Problem solving

FDA regulations

Integrity & quality

Mathematics

Legible handwriting

Computer proficiency

Flexible scheduling

Document review

Employee observations

SOPs & protocols

cGMP understanding

Education

High school diploma or GED

Job description

Grifols Shared Services North America, Inc. seeks a Quality Systems Associate to support quality assurance and training functions within a donor center environment.

Under supervision, you will ensure adherence to cGMP, SOPs, and regulatory requirements while performing product release activities and documenting deviations. The role emphasizes reviewing donor center records, training audits, and maintaining compliance with internal standards.