Quality Assurance & Training Specialist

Grifols; Inkster (MI); On-site; USD 60,000 - 80,000; Full time

Job summary

Grifols is seeking a Quality Systems Associate to support QA and training functions in a plasma center environment. The role ensures compliance with internal and external regulations and protocols, performing product release activities, reviewing records, and assisting with deviations investigations.

Under supervision of the Quality Systems Manager, you will help ensure donor safety, proper documentation, and adherence to SOPs and regulatory requirements, while contributing to continuous quality

Qualifications

• High school diploma or GED is required.
• State licensures or certifications may be required if applicable.
• Typically no prior related experience is needed.

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 coordination

Root-cause analysis

FDA regulations understanding

Documentation review

cGMP knowledge

Education

High school diploma or GED

State licensure or certifications if applicable

Job description

Grifols is seeking a Quality Systems Associate to support QA and training functions in a plasma center environment. The role ensures compliance with internal and external regulations and protocols, performing product release activities, reviewing records, and assisting with deviations investigations.

Under supervision of the Quality Systems Manager, you will help ensure donor safety, proper documentation, and adherence to SOPs and regulatory requirements, while contributing to continuous quality