Quality Assurance Specialist

1 week ago


Peoria, Illinois, United States Biomat USA Full time
Job Title: Quality Systems Associate

Grifols is seeking a highly motivated and detail-oriented Quality Systems Associate to join our team. As a Quality Systems Associate, you will play a critical role in ensuring the quality and compliance of our products and processes.

Key Responsibilities:
  • Perform quality assurance and training functions to ensure compliance with internal and external regulations and protocols.
  • Review and investigate deviations and customer complaints related to product quality and donor safety.
  • Inspect and release incoming supplies, and investigate and report any supplies that do not meet quality specifications.
  • Perform documentation reviews for unsuitable test results and assist the Quality Systems Manager in ensuring compliance with cGMP regulations and SOPs.
  • Assist with product release activities, review lookback information and documentation, and review waste shipment documentation.
  • Review unexpected plasmapheresis events, including electronic donor chart and related documentation.
  • Review electronic donor chart exceptions impacting donor eligibility/safety and/or product quality.
  • Review donor deferral notifications from competitor centers and review plasma processing documentation to ensure proper freezing, storage, and handling of product.
Additional Responsibilities:
  • Assist the Quality Systems Manager in ensuring center training programs follow procedural requirements.
  • Create, maintain, and audit training records and files to ensure compliance.
  • Perform employee training observations to ensure staff competency prior to releasing employees to work independently.
  • Conduct required training activities for Center Notifications, Corporate Directives, SOP changes, and initial SOP implementations.
Requirements:
  • High school diploma or GED.
  • Ability to understand FDA regulations and cGMP principles.
  • Strong integrity and commitment to quality and compliance.
  • Good knowledge of mathematics and legible handwriting.
  • Proficiency with computers and ability to work flexible scheduling to meet business needs.
  • Ability to spend hours sitting and reviewing documentation for accuracy.
Working Conditions:

Work is performed in a plasma center with potential exposure to biological fluids and infectious organisms. Personal protective equipment is required. Work is performed mostly while sitting for up to 4 to 6 hours per day and standing from 2 to 4 hours per day.

Grifols provides equal employment opportunities to applicants and employees without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other characteristic or status protected by law.



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