Quality Assurance & Training Specialist

Grifols, S.A; Bryan (TX); On-site; USD 65,000 - 75,000; Full time

Job summary

Grifols is a global healthcare company dedicated to improving health worldwide. The Quality Systems Associate will work under the Quality Systems Manager to ensure compliance with regulations and internal protocols, performing QA and training functions.

Responsibilities include reviewing equipment QC and maintenance records, investigating deviations and donor safety events, releasing supplies, and ensuring cGMP, SOPs, and regulatory requirements are followed.

Qualifications

• QA and regulatory compliance understanding
• Ability to review documentation for accuracy
• Strong attention to detail and organizational skills
• Understanding of FDA regulations and cGMP practices
• Experience performing training observations and SOP adherence

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.
• Inspects and releases incoming supplies and reports items not meeting quality specifications.
• Performs documentation review for unsuitable test results.
• Assists with ensuring cGMP regulation and SOP compliance across the center.
• Performs product release activities and reviews lookback information and disposal documentation.
• Reviews donor center adverse events reports and related documentation.
• Provides training support to center staff and participates in training program execution.

Skills

Quality assurance

Documentation review

Root cause analysis

cGMP awareness

SOP compliance

Education

High school diploma or GED

Job description

Grifols is a global healthcare company dedicated to improving health worldwide. The Quality Systems Associate will work under the Quality Systems Manager to ensure compliance with regulations and internal protocols, performing QA and training functions.

Responsibilities include reviewing equipment QC and maintenance records, investigating deviations and donor safety events, releasing supplies, and ensuring cGMP, SOPs, and regulatory requirements are followed.