Quality Systems & Training Specialist

Grifols, S.A; Channelview (TX); On-site; USD 58,000 - 72,000; Full time

Job summary

Grifols, S.A. is seeking a Quality Systems Associate to support QA/QC and training functions in a plasma center setting. The role ensures compliance with cGMP, SOPs, and regulatory requirements while assisting with documentation and product release activities.

Responsibilities include weekly equipment QC reviews, investigating deviations, and reviewing donor center events to maintain product quality and donor safety. Strong attention to detail and communication are essential.

Qualifications

• Must have a high school diploma or GED and be able to understand FDA regulations.
• Ability to review documentation, follow SOPs, and maintain accurate records.
• Strong communication and problem-solving abilities to support quality systems.
• No prior experience required; training provided for cGMP compliance.

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 and reports supplies not meeting quality specs.
• Performs documentation reviews for unsuitable test results.
• Assists the Quality Systems Manager to ensure cGMP and regulatory compliance; performs product release activities.
• Reviews donor events, adverse events, and donor center documentation to ensure proper handling and safety.

Skills

Interpersonal communication

Organizational skills

Problem-solving

FDA regulations understanding

Education

High school diploma or GED

Job description

Grifols, S.A. is seeking a Quality Systems Associate to support QA/QC and training functions in a plasma center setting. The role ensures compliance with cGMP, SOPs, and regulatory requirements while assisting with documentation and product release activities.

Responsibilities include weekly equipment QC reviews, investigating deviations, and reviewing donor center events to maintain product quality and donor safety. Strong attention to detail and communication are essential.