Quality Assurance & Training Specialist

Grifols; Savannah (GA); On-site; USD 52,000 - 76,000; Full time

Job summary

Grifols is seeking a Quality Systems Associate to support QA and training functions in a Savannah plasma center. Under supervision, you will review equipment records, investigate deviations, ensure product release activities, and maintain training records to comply with cGMP and SOPs.

The role emphasizes documentation, regulatory understanding, and the ability to work flexible hours with strong attention to detail and integrity in quality systems.

Qualifications

• Developing command of interpersonal communication, organizational and problem-solving skills.
• Ability to understand FDA regulations.
• Strong integrity and commitment to quality and compliance.
• Good knowledge of mathematics.
• Legible handwriting.
• Proficiency with computers.
• Ability to work flexible scheduling to meet business needs.
• Performs basic document review and employee observations.
• Ability to understand and follow SOP's and protocols.

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.
• Under the direct supervision of the Quality Systems Manager, perform quality assurance and Training functions to ensure compliance with internal and external regulations and protocol.
• 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.
• Assist the Quality Systems Manager to ensure center training programs follow procedural requirements as defined in the donor center SOP and/or training programs documents.
• Creates, maintains, and audits training records and files to ensure compliance.
• Performs employee training observations to ensure staff competency prior to releasing employees to work independently.
• Conducts required training activities for Center Notifications, Corporate Directives, SOP changes, and initial SOP implementations.
• On an occasional basis, when the Quality Systems Manager is absent, the Quality Systems Associate may be required to perform the following duties:
• Reviews and approves of deferred donor reinstatement activities.
• Assists with completion of the internal donor center audit.
• Summary: Performs review of monthly trending report.
• Performs review of donor adverse events reports and the applicable related documentation.
• Conducts training to address donor center corrective and preventative measures.

Skills

Interpersonal

FDA rules

Integrity

Math skills

Documentation

Computers

SOP compliance

cGMP basics

Time management

Education

High school diploma or GED

Job description

Grifols is seeking a Quality Systems Associate to support QA and training functions in a Savannah plasma center. Under supervision, you will review equipment records, investigate deviations, ensure product release activities, and maintain training records to comply with cGMP and SOPs.

The role emphasizes documentation, regulatory understanding, and the ability to work flexible hours with strong attention to detail and integrity in quality systems.