Quality Systems Specialist - Training & Compliance

Grifols; Town of Texas (WI); On-site; USD 55,000 - 75,000; Full time

Job summary

Grifols is seeking a Quality Systems Associate to support QA and Training functions under the Quality Systems Manager. This role ensures compliance with cGMP, SOPs, and regulatory requirements, including document reviews, deviations, and product release activities.

The position involves reviewing monthly trends, donor center documentation, and training records, with emphasis on accuracy, problem-solving, and adherence to quality standards in a plasma center environment.

Qualifications

• High school diploma or GED; state licensures or certifications if applicable.
• Typically requires no previous related experience.
• Developing command of interpersonal communication, organizational and problem-solving skills.

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.

Skills

Quality assurance

Training management

cGMP compliance

Documentation review

Education

High school diploma or GED

Tools

PC proficiency

Job description

Grifols is seeking a Quality Systems Associate to support QA and Training functions under the Quality Systems Manager. This role ensures compliance with cGMP, SOPs, and regulatory requirements, including document reviews, deviations, and product release activities.

The position involves reviewing monthly trends, donor center documentation, and training records, with emphasis on accuracy, problem-solving, and adherence to quality standards in a plasma center environment.