Quality Systems Specialist — QA & Training

Grifols; Idaho; Presencial; USD 55.000 - 75.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

None

Descripción de la vacante

Grifols is seeking a Quality Systems Associate to support quality assurance and training activities within our Boise plasma center. Under the supervision of the Quality Systems Manager, you will ensure compliance with internal and external regulations and perform product release activities and documentation reviews.

You will assist with training program development, records audits, and employee observations to verify competency before staff operate independently.

Formación

• High school diploma or GED.
• Obtains state licensures or certifications if applicable.
• Typically requires no previous related experience.

Responsabilidades

• 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.

Conocimientos

Interpersonal Skills

Organizational Skills

Problem Solving

FDA Regulations

Quality Systems

Educación

High School Diploma or GED

Descripción del empleo

Grifols is seeking a Quality Systems Associate to support quality assurance and training activities within our Boise plasma center. Under the supervision of the Quality Systems Manager, you will ensure compliance with internal and external regulations and perform product release activities and documentation reviews.

You will assist with training program development, records audits, and employee observations to verify competency before staff operate independently.