Quality Assurance Specialist

4 weeks ago

Oklahoma City, Oklahoma, United States Biomat USA Full time
Quality Systems Associate Job Description

Biomat USA is seeking a highly skilled 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 plasma center operations.

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.
  • Assist the Quality Systems Manager in ensuring compliance with cGMP regulations, SOPs, and regulatory requirements.
  • Perform 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.
  • 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.
  • Conduct required training activities for Center Notifications, Corporate Directives, SOP changes, and initial SOP implementations.
Requirements:
  • High school diploma or GED.
  • Typically requires no previous related experience.
  • 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.

Biomat USA 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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