Quality Assurance Specialist

4 weeks ago


Huntsville, Alabama, United States GRIFOLS, S.A. Full time
Job Summary:

Grifols, a global healthcare company, is seeking a Quality Assurance Specialist to join our team in Huntsville, AL. As a Quality Assurance Specialist, you will play a critical role in ensuring the quality and compliance of our plasma center operations.

About Grifols:

Grifols is a leading 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.

Key Responsibilities:
  • Perform quality assurance and training functions to ensure compliance with internal and external regulations and protocols.
  • Review and document equipment QC and maintenance records.
  • Investigate and perform root-cause analysis for deviations and customer complaints related to product quality and/or donor safety.
  • Inspect and release incoming supplies, investigating and reporting supplies that do not meet quality specifications and requirements prior to use.
  • Perform documentation review for unsuitable test results.
  • Assist the Quality Systems Manager to ensure compliance with cGMP regulation, SOPs, and regulatory requirements.
  • Perform product release activities.
  • Review lookback information and documentation.
  • 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.
Required Skills and Qualifications:
  • High school diploma or GED.
  • No previous related experience required.
  • Certification as a Donor Center Technician.
  • Developing command of interpersonal communication, organizational, and problem-solving skills.
  • Ability to understand FDA regulations.
  • Strong integrity and commitment to quality and compliance.
  • Good knowledge of mathematics.
  • Legible handwriting.
  • Proficiency with computers.
  • Ability to work flexible scheduling to meet business needs.
  • Ability to understand and follow SOPs and protocols.
Benefits:
  • Competitive salary range: $55,000 - $65,000 per year, based on location and experience.
  • Benefits package, including medical, dental, and vision insurance.
  • 401(k) retirement plan with company match.
  • Opportunities for professional growth and development.
  • A dynamic and supportive work environment.
Location:

Huntsville, AL - USA

We are an equal opportunity employer and welcome applications from diverse candidates. If you are a motivated and detail-oriented individual who is passionate about quality and compliance, we encourage you to apply for this exciting opportunity.



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