Quality Systems & Training Specialist

RXinsider LTD.; Channelview (TX); On-site; USD 42,000 - 56,000; Full time

Job summary

Grifols is seeking a Quality Systems Associate in Texas to support quality assurance and training programs within a plasma center. Under supervision, you will help ensure compliance with cGMP, SOPs, and regulatory requirements while participating in product release and documentation reviews.

You will assist in maintaining training records, conducting employee observations, and supporting center notifications and directives.

Qualifications

• High school diploma or GED. Obtains state licensures or certificates if applicable.
• Typically requires no previous related experience.
• Ability to understand FDA regulations and cGMP quality systems.

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; investigates and reports supplies not meeting quality specs prior to use.
• Performs documentation review for unsuitable test results.
• Assist the Quality Systems Manager to ensure compliance with SOPs and regulatory requirements.

Skills

Quality assurance

Training

Root-cause analysis

Documentation review

cGMP

SOP compliance

FDA regulations

Education

High school diploma

Job description

Grifols is seeking a Quality Systems Associate in Texas to support quality assurance and training programs within a plasma center. Under supervision, you will help ensure compliance with cGMP, SOPs, and regulatory requirements while participating in product release and documentation reviews.

You will assist in maintaining training records, conducting employee observations, and supporting center notifications and directives.