Quality Assurance & Training Specialist - Plasma Center

Grifols; Columbia Township (MO); On-site; USD 52,000 - 76,000; Full time

Job summary

Grifols is seeking a Quality Systems Associate to join our international healthcare team in the United States. Under the supervision of the Quality Systems Manager, you will perform quality assurance and training duties to ensure compliance with cGMP and regulatory requirements within the donor center environment.

You will review equipment QC, investigate deviations, assist with center training programs, and participate in product release activities, donor chart reviews, and adverse events

Qualifications

• High school diploma or GED required.
• Ability to understand FDA regulations.
• Strong integrity and commitment to quality and compliance.
• Good knowledge of mathematics.
• Legible handwriting.
• Proficiency with computers.

Responsibilities

• Performs quality assurance and training functions to ensure compliance with regulations and protocols.
• Reviews monthly trending reports and donor center adverse events.
• Documents, investigates, and performs root-cause analysis for deviations and customer complaints.
• Inspects and releases incoming supplies; reviews lookback information and documentation.
• Performs product release activities and ensures proper freezing, storage and handling of plasma products.
• Maintains and audits training records and files; conducts training observations to ensure staff competency.

Skills

Interpersonal communication

Organizational skills

Problem-solving

FDA regulations knowledge

Integrity/compliance

Mathematics literacy

Attention to detail

Proficiency with computers

Education

High school diploma or GED

Donor Center Technician certification (if applicable)

State licensure/certifications as applicable

Job description

Grifols is seeking a Quality Systems Associate to join our international healthcare team in the United States. Under the supervision of the Quality Systems Manager, you will perform quality assurance and training duties to ensure compliance with cGMP and regulatory requirements within the donor center environment.

You will review equipment QC, investigate deviations, assist with center training programs, and participate in product release activities, donor chart reviews, and adverse events