Quality Systems Specialist – Compliance & Training

Grifols Shared Services North America, Inc; Laredo (TX); On-site; USD 42,000 - 56,000; Full time

Job summary

Grifols Shared Services North America, Inc in Laredo, TX is seeking a Quality Systems Associate to support QA and training under the Quality Systems Manager, ensuring compliance with FDA, cGMP, SOPs, and donor center procedures.

The role includes reviewing QC and maintenance records, investigating deviations and donor safety issues, approving product releases, and maintaining training records to ensure staff competency.

Qualifications

• QA/QC and training in a regulated environment.
• Knowledge of FDA regulations and cGMP.
• Documentation review and deviation investigation.
• Ability to work with SOPs and regulatory requirements.

Responsibilities

• Complete weekly review of equipment QC and maintenance records.
• Investigate deviations and customer complaints related to quality or donor safety.
• Inspect and release incoming supplies; report any that do not meet quality specs.
• Perform documentation review for test results and product release activities.
• Review donor charts, regulatory documentation, and exceptions affecting eligibility/safety.

Skills

Quality assurance

Training

FDA regulations

cGMP

Documentation

Problem solving

Education

High school diploma or GED

Job description

Grifols Shared Services North America, Inc in Laredo, TX is seeking a Quality Systems Associate to support QA and training under the Quality Systems Manager, ensuring compliance with FDA, cGMP, SOPs, and donor center procedures.

The role includes reviewing QC and maintenance records, investigating deviations and donor safety issues, approving product releases, and maintaining training records to ensure staff competency.