Quality Assurance Specialist

3 weeks ago


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

Grifols is a global healthcare company that has been working to improve the health and well-being of people around the world since 1909. We are leaders in plasma-derived medicines and transfusion medicine, and we develop, produce, and market innovative medicines, solutions, and services in over 110 countries and regions.

Job Summary:

Under the direct supervision of the Quality Systems Manager, the Quality Systems Associate will perform quality assurance and training functions to ensure compliance with internal and external regulations and protocols. This role will be responsible for completing weekly reviews of equipment QC and maintenance records, documenting and investigating deviations and customer complaints, and inspecting and releasing incoming supplies.

Key Responsibilities:
  • Completes weekly review of equipment QC and maintenance records.
  • Documents, investigates, and performs root-cause analysis for deviations and customer complaints.
  • Inspects and releases incoming supplies.
  • 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.
  • Reviews electronic donor chart exceptions.
  • Reviews donor deferral notifications.
  • Reviews plasma processing documentation.
Additional Responsibilities:
  • Assists the Quality Systems Manager to ensure center training programs follow procedural requirements.
  • Creates, maintains, and audits training records and files.
  • Performs employee training observations.
  • Conducts required training activities.
Requirements:
  • High school diploma or GED.
  • Obtains state licensures or certifications if applicable.
  • Typically requires no previous related experience.
Working Conditions:

Work is performed in a plasma center. Exposure to biological fluids with potential exposure to infectious organisms. Exposure to electrical office and laboratory equipment. Exposure to extreme cold below 32 degrees F while performing reviews in plasma freezers. Personal protective equipment is required.



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