Quality Assurance Specialist

1 week ago

Bakersfield, California, 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 is responsible for reviewing 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, specifically in how they relate to product quality and/or donor safety.
  • Inspects and releases incoming supplies. Investigates and reports supplies that 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.
  • Reviews donor deferral notifications from competitor centers.
  • Reviews plasma processing documentation to ensure the proper freezing, storage, and handling of product.
  • Assists the Quality Systems Manager to ensure center training programs follow procedural requirements as defined in the donor center SOP and/or training programs documents.
  • Creates, maintains, and audits training records and files to ensure compliance.
  • Performs employee training observations to ensure staff competency prior to releasing employees to work independently.
  • Conducts required training activities for Center Notifications, Corporate Directives, SOP changes, and initial SOP implementations.
Requirements:
  • High school diploma or GED.
  • Obtains state licensures or certifications if applicable.
  • Typically requires no previous related experience.
Work Environment:

The work environment is a plasma center, and the employee may be exposed to biological fluids with potential exposure to infectious organisms. Personal protective equipment is required, including protective eyewear, garments, gloves, and cold-gear. The employee will work 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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