Quality Assurance & Training Specialist

Grifols, S.A; Florida; Hybrid; USD 55,000 - 75,000; Full time

Job summary

Grifols, S.A. is seeking a Quality Systems Associate to support QA and training, ensuring compliance with cGMP and SOPs. You will assist the Quality Systems Manager, participate in product release, and review donor center documentation to uphold donor safety and product quality.

Responsibilities include routine QC reviews, deviation investigations, and handling of supplier documentation. This role is based in a donor center environment with emphasis on accuracy and regulatory adherence.

Qualifications

• High school diploma or GED; state licensures or certifications if applicable.
• Experience in quality systems or donor center operations is a plus.
• Ability to interpret cGMP and regulatory requirements.

Responsibilities

• Completes weekly review of equipment QC and maintenance records.
• Documents, investigates, and performs root-cause analysis for deviations and customer complaints, specifically in how they related to product quality and/or donor safety.
• Inspects and releases incoming supplies. Investigates and reports supplies have not met quality specifications and requirements prior to use.
• Performs documentation review for unsuitable test results.
• Assists the Quality Systems Manager to ensure that cGMP regulation, SOPs and regulatory requirements are followed.
• Performs all product release activities.
• Reviews lookback information and documentation.
• Reviews waste shipment documentation.
• Reviews unexpected plasmapheresis events including electronic donor chart and related documentation pertaining to exceptions occurring during the donation process.
• Reviews electronic donor chart exceptions impacting donor eligibility/safety and/or product quality.
• Reviews donor deferral notifications from competitor centers.
• Reviews plasma processing documentation to ensure the proper freezing, storage and handling of product.

Skills

Quality Assurance

Training

Document Review

Root Cause Analysis

cGMP Knowledge

FDA Regulations

Interpersonal Skills

Education

High School Diploma or GED

Job description

Grifols, S.A. is seeking a Quality Systems Associate to support QA and training, ensuring compliance with cGMP and SOPs. You will assist the Quality Systems Manager, participate in product release, and review donor center documentation to uphold donor safety and product quality.

Responsibilities include routine QC reviews, deviation investigations, and handling of supplier documentation. This role is based in a donor center environment with emphasis on accuracy and regulatory adherence.