Donor Center QA & Training Specialist

Grifols

Zanesville (OH)

Presencial

USD 55.000 - 75.000

Jornada completa

hace 41 horas
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Descripción de la vacante

Grifols in the United States seeks a Quality Systems Associate to support QA and training functions, ensuring compliance with regulatory requirements and company SOPs. Under the supervision of the Quality Systems Manager, you will help manage documentation, review records, and participate in product release activities.

This role involves root-cause analysis of deviations, inspection of supplies, maintenance reviews, and maintaining center training records, with occasional duties when the manager

Formación

  • High school diploma or GED is required; state licensures or certifications optional.
  • No prior related experience required.
  • Strong knowledge of FDA regulations and cGMP.
  • Excellent attention to detail and documentation skills.
  • Ability to train others and maintain training records.
  • Ability to work under direct supervision and follow SOPs.

Responsabilidades

  • Completes weekly review of equipment QC and maintenance records.
  • Documents, investigates, and performs root-cause analysis for deviations and complaints.
  • Inspects and releases incoming supplies and reports nonconforming items.
  • Performs documentation review for test results and release decisions.
  • Supports cGMP compliance and training programs.
  • Conducts monthly training observations and audits.
  • Participates in internal donor center audits and reviews adverse events.

Conocimientos

Interpersonal communication
Organizational skills
Problem-solving
FDA regulations knowledge
Quality systems compliance
Attention to detail
Documentation review
Training observation
cGMP understanding

Educación

High school diploma or GED
State licensures or certifications (if applicable)

Herramientas

Computers

Descripción del empleo

Grifols in the United States seeks a Quality Systems Associate to support QA and training functions, ensuring compliance with regulatory requirements and company SOPs. Under the supervision of the Quality Systems Manager, you will help manage documentation, review records, and participate in product release activities.

This role involves root-cause analysis of deviations, inspection of supplies, maintenance reviews, and maintaining center training records, with occasional duties when the manager

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